98140 Comparative Analysis of Certain Requirements of Food Legislation in the European Union and the Customs Union of Russia, Belarus, and Kazakhstan In partnership with: ©2015 The World Bank Group 1818 H Street N.W., Washington D.C., 20433 All rights reserved. May 2015 This work is a product of the staff of the World Bank Group with external contributions. The information included in this work, while based on sources that the World Bank Group considers to be reliable, is not guaranteed as to accuracy and does not purport to be complete. The World Bank Group accepts no responsibility for any consequences of the use of such data. The information in this work is not intended to serve as legal advice. The findings and views published are those of the authors and should not be attributed to IFC, the World Bank, the Multilateral Investment Guarantee Agency (MIGA), or any other affiliated organizations. 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In partnership with: Content Comparative Analysis of Requirements and Arrangements of Food Control between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union..................................................5 Executive Summary ................................................................................................................................................................................6 Important Notes for Governments, Policy Makers and Businesses.........................................................................22 Requirements to Food Quality in the European Union and the Customs Union .................................................. 25 Executive Summary .............................................................................................................................................................................26 Historical Context..................................................................................................................................................................................28 Determining the Criteria and Scope of the Comparative Analysis of the EU and CU Requirements Related to Food Quality.....................................................................................................................................30 Comparison of the Specific Quality Characteristics between the Customs Union and European Union ...................................................................................................................................... 33 Important Notes for Governments, Policy Makers and Industry ..............................................................................38 Requirements to Food Labeling in the European Union and the Customs Union ............................................... 41 Executive Summary .............................................................................................................................................................................42 General Comparison between the Customs Union and European Union Legal Frameworks on Food Labeling ..................................................................................................................................................................................43 Comparison of Specific Labeling Requirements of the Customs Union and the European Union ..................................................................................................................................................................44 Important Notes for Governments, Policy Makers and Industry .............................................................................. 52 Food and Food-related Articles and Materials that Require Special Authorization ............................................... 55 Executive Summary ............................................................................................................................................................................. 56 Novel Food ................................................................................................................................................................................................ 56 Dietary Supplements ...........................................................................................................................................................................62 Food Additives ........................................................................................................................................................................................ 65 Materials and Articles in Contact with Food ..........................................................................................................................71 Considerations ........................................................................................................................................................................................ 76 Laboratory Control and Food Safety Criteria in the European Union and the Customs Union .................... 79 Executive Summary .............................................................................................................................................................................80 Microbiological Criteria for Foodstuffs – Approaches and a Comparison of Parameters...........................81 Contaminants in Food .......................................................................................................................................................................86 Maximum Residue Limits (MRLs) for Residues of Pesticides .......................................................................................89 Maximum Residue Levels for Residues of Pharmacologically Active Substances ..........................................92 Approaches to Laboratory Control, Sampling and Testing ..........................................................................................98 Important Notes for Governments, Policy Makers and Businesses.......................................................................102 3 Foreword This report presents a comparative analysis of the food legislation requirements of the European Union and the Customs Union. Its purpose is to guide food business operators and public authorities engaged in reforming national food safety systems in the peculiarities of EU and Customs Union legal requirements and help them evaluate their capabilities in meeting those require- ments. This report supports the International Finance Corporation’s efforts to facilitate the opening of new markets for the producers in emerging markets. Public authorities will find this report useful for aligning their national food safety policies and frameworks with the EU and Customs Union. Similarly, food producers looking to export their products to these markets will be able to align their food safety control systems with target markets. This report compares the most critical aspects of food legislation of the EU and the Customs Union, such as:  Requirements and Arrangements of Food Control;  Requirements to Food Quality;  Requirements to Food Labeling;  Food and Food-related Articles and Materials that Require Special Authorization;  Laboratory Control and Food Safety Criteria. Food safety standards are a major driver of food production and trade. Consumers want safe food which is sustainably produced and can be traced back to individual producers. Ensuring food safety and consumer protection increasingly occupy the agendas of governments, which are looking to expand their trade networks. Likewise, food businesses interested in widening their export range need to understand quality and safety requirements in their target markets. This report offers unique, up-to-date information on the similarities and differences of the food safety requirements of the EU and Customs Union, with detailed assessments of the regulations that govern food safety. Lisa Kaestner, Rufat Alimardanov, Practice Manager, Country Manager, Trade and Competitiveness IFC in Ukraine and Global Practice, Europe and Belarus Central Asia World Bank Group Comparative Analysis of Certain Requirements of Food Legislation in the European Union 4 and the Customs Union of Russia, Belarus, and Kazakhstan Acknowledgement The Investment Climate for Agribusiness Project in Ukraine wishes to thank the Swiss Development Agency (SECO) for their generous support in funding the development of the “Comparative Analysis of Certain Requirements of Food Legislation in the European Union and the Customs Union of Russia, Belarus, and Kazakhstan”. The preparation and publication of the comparative analysis involved the participation and efforts of a number of dedicated people. Primary contribution was provided by Kateryna Onul, Adviser on Food legislation of the Investment Climate for Agribusiness Project in Ukraine with the support of T&M Associates consultancy and personally, Anna Vasylenko. We would like to recognize Eugen Osmochescu, Selma Rasavac-Avdagic, Heinz Strubenhoff, Serhiy Osavolyuk, and Victoria Tetyora for their valuable comments and peer review. We are happy to acknowledge that the Ministry of Agrarian Policy and Food of Ukraine, and a number of business associations heartily supported this publication. Special acknowledgment goes to Lisa Kaestner (WBG, Practice Manager, Trade & Competitiveness in Europe and Central Asia) for her support of the initiative. Comparative Analysis of Requirements and Arrangements of Food Control 5 between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union Important Note This analytical report had been prepared in April- November 2014. While the publication was in the process of preparation, the Customs Union underwent a number of important changes: on January 1st, 2015, an agreement on establishing the Eurasian Economic Union (EEU) entered into force; it is planned that from January 1, 2016 the Single Economic Space will become fully functioning. Further, Armenia and Kyrgyzstan joined Belarus, Kazakhstan and Russia as the Customs Union member states. Still, all those changes have not impacted approaches to food safety policy. All legal documents of the Customs Union used for this analysis remain in full force. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 6 and the Customs Union of Russia, Belarus, and Kazakhstan Comparative Analysis of Requirements and Arrangements of Food Control between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union declare safety and conformity of the product, it is still the government who authorizes the declaration. The government sets the specifications which typically in- clude many attributes related to food quality as well as safety and then verifies compliance through inspection and testing. Industry is only required to provide a final Executive Summary product that complies with the technical specification. In comparison, the European Union food control sys- nsuring food safety is a key shared responsibility of tem is based on risk control and mitigation. Within the E both governments and industry. Failure to deliver on this commitment has led to illness and death. It impacts a country’s ability to trade and therefore the risk-based approach, food business operators are re- sponsible for identifying food safety hazards and related risks from farm-to-fork and developing and implement- economic well-being of the country. For these reasons ing practices that prevent, minimize or eliminate those globally governments and industry expend significant hazards (HACCP)1, while the government is responsible efforts and resources to ensure that food is safe and for monitoring and verifying the effectiveness of the risk governments have established systems for food control. control measures. In the European Union risk-based sys- These food control systems have 5 common elements: tem, food quality attributes such as size, color, shape, food laws and regulations that provide the legal basis smell and taste are not generally a part of the food con- and regulatory requirements of the system; food control trol system. Instead, they are left to the market place to management systems that establish the roles and judge if they are acceptable. These two approaches to responsibilities of government and industry; inspection food control are fundamentally different. The Customs services that monitor and enforce the regulations Union is based on end-product compliance to a specific and ensure that the proper activities are taking place; technical regulation or standard, whereas the European laboratory services for monitoring through testing Union is based on preventive measures and minimizing compliance with the regulations; and information, risks associated with each process throughout the com- education and training for industry, government and plete food chain. These differences have significant im- consumers. plications for content and organization of the laws and regulations, monitoring and control, inspection, testing, While each food control system has these elements, the labeling, approaches to food quality, and the responsi- approach and specifics differ. In each country and union bilities of government, industry and consumers in en- of countries, the food control system reflects their spe- suring that the food is safe. Both systems are effective, cific needs, historical context, and culture. The Customs but the differences in philosophy, organization, imple- Union food control system is based on ensuring the mentation and enforcement have significant impact on safety of food through compliance with final product both business operators wishing to export to either or specifications. In this system, responsibility for food both of the Unions and countries wishing to harmonize safety mainly resides with food control bodies, and they with either Union. For industry, these differences require accomplish this task by verifying that the end-product extensive working knowledge of the specifics of each meets the required technical specification established by system, and the ability to adjust their processes and the government. Even when a producer is required to products accordingly. 1 HACCP – Hazard Analysis and Critical Control Points – A science-based system that identifies, evaluates and controls hazards that are sig- nificant for food safety. HACCP is a tool to assess hazards and establish control systems that focus on prevention rather than relying mainly on end-product testing. HACCP is based on seven principles: (1) identifying any hazards that must be prevented, eliminated or reduced to acceptable levels (hazard analysis); (2) identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels; (3) establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards; (4) establishing and implementing effective moni- toring procedures at critical control points; (5) establishing corrective actions when monitoring indicates that a critical control point is not under control; (6) establishing procedures, which shall be carried out regularly, to verify that the measures outlined in paragraphs 1 to 5 are working effectively; (7) establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in paragraphs 1 to 6. See Codex Alimentarius document . Hazard Analysis and Critical Control Point (HACCP) system and guidelines for its application, Annex to CAC/RCP 1-1969. Recommended international code of practice general principles of food hygiene, and EU Guidance document on the implementation of procedures based on the HACCP principles, and on the facilitation of the implementation of the HACCP principles in certain food businesses, European Commission Health & Consumer Protection Directorate-General Brussels, 16 November 2005; Comparative Analysis of Certain Requirements of Food Legislation in the European Union 8 and the Customs Union of Russia, Belarus, and Kazakhstan The differences can be better elucidated through the food is NOT covered by technical harmonization within following. In general, the Customs Union has adopted the “New Approach”, and all of the above features are an approach to technical regulation that is very similar not applicable to foodstuffs. In the European Union this to the one used in the European Union (the so called “New Approach” has not been extended to food control “new EU approach to technical harmonization and stan- as there has been significant reluctance to allow food dards”)2 for a wide range of consumer goods and indus- safety to be determined by standards bodies (usually trial items (toys, cosmetics, electric equipment, elevators, representing a third party) that operate outside the gov- high-pressure vessels, and many others) with one sig- ernmental framework and who have little tradition or nificant exception, in the European Union this “new ap- experience in defining, controlling, or managing food proach” does not cover foodstuffs. The main features safety. Food Safety is deemed too important for govern- of technical regulation and harmonization common to ments, industry and consumers to relinquish control. both Unions for non-food items include: In the Customs Union, the use of technical regulations  legislative harmonization is limited to essential as an approach to control safety has been extended to safety requirements; essential safety require- foodstuffs. The extension of the technical regulations to ments are outlined in mandatory sectorial direc- food by the Customs Union is the fundamental reason tives (EU), or in technical regulations (CU); for the significant divergence of the Customs Union and  products for which essential safety requirements European Union food control systems. are developed may be placed on the market only if they do not endanger the safety of persons, The differences start with the mandate, general orga- goods, etc.; nization, and application of food control within each  drawing up technical production specifications Union. The European Union and the Customs Union (standards) is acceptable and is entrusted to orga- nizations competent in industrial standardization; have their own mandates, scopes and degrees of inte-  technical specifications (standards) are not gration that influence the entire regulatory framework mandatory; in general, and the food control system in particular at  the public authorities must ensure the protection the all-union level and at the level of member states. of safety (or other requirements envisaged) on The Customs Union focuses primarily on internal trade their territory; between member states and therefore issues customs  the public authorities are obliged to recognize policy and rules for allowing commodities into circula- that products manufactured in conformity with tion. In this system there are a number of general and harmonized standards are presumed to conform product-specific technical regulations that provide a to the essential requirements; in the absence of framework for food control within the Customs Union. harmonized standards, public authorities accept The common framework is then supported by mem- conformity with national standards; ber states national laws, regulations, and standards. Also,  member states presume conformity for products within the Customs Union, for food categories where which are accompanied by a means of attesta- tion, and these products are allowed to freely cir- product-specific technical regulations have not been culate on the market; developed yet, the national law of member states ap-  means of attestation are: plies. Figure 1 provides a graphical representation of the  certificates and marks of conformity, Customs Union food-related legal instruments.  test results,  a declaration of conformity issued by the In order to be compliant with the Customs Union, one manufacturer, which may be coupled with a has to take into consideration compliance with the surveillance system; Union’s technical regulations as well as the laws and  member states designate bodies authorized to is- standards of the member states. Further, for business sue marks or certificates of conformity; operators it is important to note that the Customs Union  as a visual sign of conformity, a mark is placed on system does not address such aspects as enforcement, the label (“EAC” mark in the Customs Union, and fines, penalties, incident management, recalls and with- “CE” mark in the European Union”. drawals, and authorization/approval of new substance The significant difference between the Customs Union (pesticides or veterinary medicines), leaving those to be and the European Union is that in the European Union, under the mandate of the national law of the member 2 Council Resolution 85/C 136/01 of 7 May 1985 on a new approach to technical harmonization and standards. Comparative Analysis of Requirements and Arrangements of Food Control 9 between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union states. This increases the complexity of the regulatory financial, monetary, political, social, scientific, security environment and compliance for industry wishing to and many other areas. Because the mandate and focus export to the Union and for governments wishing to of the European Union is much broader, the food con- model or harmonize with the Customs Union. trol system takes into account a greater range of issues which are reflected in the regulatory framework. Further, The European Union has taken a different approach the European Union regulations3 supersede those of and has a much broader agenda, covering economic, the member states, which creates a harmonized and Figure 1 Organization of Customs Union Technical Regulations Decisions of the Commission Framework agreements of the CU on procedural aspects (e.g., on common principles (e.g., border control, joint checks in third countries) of technical regulation) FOOD NON-FOOD Sanitary, Epidemiology Technical Regulations and Hygiene Requirements Chapter II, section 1: Safety requirements CU TR 021/2011 “On food safety” and nutritional value of food (all food categories) Chapter II, section 9: Requirements CU TR 005/2011 “On the safety of packaging” for drinking water packed in containers CU TR 022/2011 “On food products Chapter II, section 15: Requirements in terms of their labeling” for pesticides CU TR 029/2012 “Requirements for the safety Chapter II, section 16: Requirements of food additives, flavorings for food contact materials and technological aids” Chapter II, section 21: Requirements CU TR 033/2013 “On milk and dairy products” for mineral water CU TR 034/2013 “On meat and Chapter II, section 22: Requirements meat products” for food additives and flavorings CU TR 023/2011 “On fruit and vegetable Chapter II, section 23: Requirements Juice products ” for processing aids CU TR 024/2011 “On Oils and Fats” Uniform veterinary requirements (non-food as well) Uniform phyto-sanitary requirements CU TR 015/2011 “On the safety of grain” Standards (national/regional CU TR 027/2012 “On safety of certain types standards (e.g., GOST, GOST-R), of specialized food products, including foods international: for dietary treatment and dietary preventive - As voluntary option of compliance nutrition with TRs Each TR establishes: - Mandatory sampling and testing methods - items and processes regulated - safety requirements - rules of identification - forms and procedures of assessment (confirmation) of conformity In case of several TRs, when they entered into force, relevant sections of the Uniform sanitary, epidemiology and hygiene requirements stopped being effective with regard to the objects of regulation covered by the TRs 3 There are three main types of legal instruments in the European Union: regulations, directives and decisions. Regulations are addressed to member states, have direct effect, supersede national law and do not require transposition; regulations by their nature are similar to laws. Directives are addressed to member states but do not establish directly applicable requirements; they set objectives that need to be trans- posed into national laws by national legal instruments. Decisions can be addressed both to member states and/or specific entities; they have direct effect but are usually focused on specific narrow issues. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 10 and the Customs Union of Russia, Belarus, and Kazakhstan unified set of horizontal legal acts across all member and management, it covers a much more comprehen- states. This simplifies compliance for industry in that one sive range of the food chain steps, from production and system is uniformly applied across all Member States. processing to sale to the final consumers. Therefore, a This uniform system defines and clearly establishes the much wider range of food business operators (virtu- European Union requirements for compliance, enforce- ally all of them) are included under the regulations. The ment, incident management, recalls and withdrawals, European Union food law is a combination of horizon- and authorization/approval of new substances (pesti- tal and a limited number of vertical legal instruments. cides, veterinary medicines, food additives, etc.). Finally, Figure 2 is a graphical depiction of the food laws within since the focus of the European Union is on risk control the European Union. Figure 2 Graphical Depiction of the Food Laws in the European Union4 EUROPEAN FOOD LAW Provisions for Public Authorities Requirements for Food Businesses GENERAL PRINCIPLES Executive tasks Requirements on product Scientific risk assessment (EFSA) Product standards (verticals) Implementing measures (EC/MS) Approval requirements Decisions (EC/MS) Food supplements Information and risk communication Food additives (EFSA/EC/MS) GMO Novel food Enforcement Food safety limits Official controls (MS) Microbiological criteria Sanctions MRLs (pesticides, veterinary drugs) Administrative (Injunctions, fines) (MS) Contaminants Criminal (fines, prison) (MS) EU second line inspections on Requirements on presentation MS enforcement (FVO) Labeling Publicity Risk communication Incident management Communication(RASFF) Requirements on process National measures (impose recall) (MS) Producer Emergency measures (European Commission) Premises Production Hygiene, HACCP Trade Traceability Withdrawals/recalls Miscellaneous i.e. food contact materials Interests of Consumers 4 This chart is adapted from The System of Food Law in the European Union, by Bernd M J Van Der Meulen// Deakin Law Review, Volume 14 No. 2, 2009. Comparative Analysis of Requirements and Arrangements of Food Control 11 between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union It is important to note that even the definition of food exclusions include for instance, cosmetics, tobacco and varies between the two Unions. Again this can be tobacco products, narcotic or psychotropic substances traced back to the differences in approach. Because the and residues and contaminants8,9. Customs Union focuses on the compliance of the final food product to a specific technical regulation or stan- The Customs Union and the European Union have both dard, the definition of food is limited to “products that established basic requirements relative to food. Food are of animal, plant, microbiological, mineral, artificial, or shall be safe, meet food safety criteria, be hygienically biotechnological origin and includes natural, processed produced and handled, registered as needed, prop- or reprocessed products intended for human consump- erly packaged, labeled, and be traceable10. This is fur- tion including drinks, chewing gum, specialized food ther elaborated on by the European Union that unsafe products, packaged potable water, potable mineral wa- food takes into account the intended use of food and ter, alcoholic products (including beer and beer-based recognizes that food is unsafe when it presents dan- drinks), non-alcoholic beverages, biologically active ger to health and is unfit for human consumption. The supplements (BAS), chewing gum, enzymes and starter Customs Union technical regulations include a number cultures of microorganisms, yeast, food additives and of requirements that relate to its circulation on the mar- flavorings as well as food raw material”5. The European ket11 that are not found in the European Union, the most Union takes a wider definition of food: “food (or ‘food- important of which is that food must pass conformity stuff’) means any substance or product, whether pro- assessment procedures and bear a special Customs cessed, partially processed or unprocessed, intended to Union mark as a proof of conformity. Further, since the be, or reasonably expected to be ingested by humans. Customs Union is based on conformity assessments, ‘Food’ includes drink, chewing gum and any substance, many food products have to meet compositional stan- including water, intentionally incorporated into the food dards, as well as requirements for chemical and physical during its manufacture, preparation or treatment”6. This properties, nutritional properties, organoleptic (appear- definition by design allows for a broader interpretation ance, taste, odor) and, in some cases, size. Within the of food giving it greater control over the products and European Union such aspects are generally, with a few substance humans may ingest. Further, it allows for ad- limited exceptions, regulated by the market place and aptation in that as science and technology advance, by the rules of providing adequate information to con- such as developments in nano-technology, the incor- sumers. Finally it must be noted in the European Union poration of new substances and products into the scope it is recognized that food can be unsafe even when it of food becomes easy. The European Union establishes conforms to specific provisions of food law. These re- a general set of exclusions in the definition of food that quirements and elaborations are important as they play further refine what food is and what food is not. These a key role in the food control system and specifically as are mostly consistent with the Customs Union7 and the they emphasize the role of the food business operator. 5 Customs Union TR 021/2011“On Food Safety”. 6 Article 2 of Regulation (EC) No. 178/2002, also commonly referred to as General Food Law. 7 Note the Customs Union does not specifically exclude these items from food but as they are not defined as food they are also excluded 8 See the companion document for a more exhaustive list of what is excluded from the definition of food. 9 There are two additional differences that should be mentioned. In the European Union medicinal products are specifically excluded. In the Customs Union they are not specifically excluded but maybe interpreted as excluded based on terminology and use within the overall framework. In the Customs Union, biologically active additives (BAA) such as probiotic microorganisms, intended for consumption to- gether with food or mixing into food products are specifically defined as food and while not specifically outlined in the European definition it does fall under substances and therefore is included as food. 10 Even though food safety is a main objective of the food law, European legal acts do not give a definition of food safety. However, Regulation (EU) No. 178/2002, Article 14, provides for a ban on unsafe food and explains when, for the purposes of the food law; food is deemed to be unsafe: “Food shall not be placed on the market if it is unsafe. Food shall be deemed to be unsafe if it is considered to be: injurious to health and/or unfit for human consumption”. Article 5, CU TR 021/2011 “On Food Safety”. 11 The term “circulation on the market” is common within the Customs Union and one that means to sell into the market place. We have chosen to use the common term so that the readers become familiar with the terms used in translation of Customs Union documents into English. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 12 and the Customs Union of Russia, Belarus, and Kazakhstan The Customs Union12 and the European Union13 have requirements (for manufacturers and importers) to the a well-defined and established system of food control. processes of production, processing, transportation, At a high level, the intent of the Customs Union and storage, sale, disposal for foodstuffs in general as well the European Union food control systems are similar: as for several categories (meat and meat products, milk to ensure the safety of food for consumers, to allow for and dairy, juices, oils and fats, grains), the implementa- free movement of goods within the Union, to protect tion and enforcement procedures are mostly those of consumers from fraud and adulteration. The Customs the individual member states. Therefore for companies Union further elaborates the intent of food control and wishing to export to the Customs Union this means establishes that technical regulation and conformity as- that they have to comply with and understand both the sessment is the framework by which food control is es- Customs Union technical regulations as well as those tablished.14 In the European Union the intent is further of the member states to which they will export prod- elaborated to preventing or eliminating risks which may uct. In addition, the role of industry is generally limited arise, either directly or via the environment, for human within the Customs Union to ensuring that the prod- beings and animals, or reduce these risks to an accept- ucts which are produced and/or imported meet the able level15. specific technical requirements as set by the Customs Union or the Member States. Contrary to the European In the Customs Union the food control system in- Union approach, industry in the Customs Union does corporates two levels: food control through all-Union not bear responsibility to define other additional self- conformity assessment and individual member state control measures to ensure food safety. Even hazards controls (supervision) of sanitary, veterinary, phytosani- within HACCP systems are limited to those specified in tary aspects.16 Implementation of routine food control the technical regulations as criteria for finished products. on a daily basis to a significant extent relies on the laws, The Customs Union institutional framework and the regulations and standards of its member states. While scope of the official food control system are represented the technical regulations set specifics of conformity and in Figure 3. 12 Agreement of the Customs Union on sanitary measures (approved by Decision of the Interstate Council of the Eurasian Economic Community No. 28 of December 11, 2009); Agreement of the Customs Union on Veterinary and Sanitary Measures of December 11, 2011, Agreement of the Customs Union on plant quarantine (approved by Decision of the Interstate Council of the Eurasian Economic Community No. 30 of December 11, 2009; Regulations on the procedure for the state sanitary and epidemiological supervision (control) of persons and vehicles crossing the customs border of the Customs Union, of controlled goods moved across the customs border of the Customs Union and the customs territory of the Customs Union (Approved by the Decision of the Customs Union Commission on May 28, 2010 No. 299); Uniform list of goods subject to sanitary and epidemiological supervision (control) at the customs border and in the cus- toms territory of the Customs Union (Approved by Decision No. 299 of the Customs Union Commission dated May 28, 2010); Common list of goods, subjected to veterinary control (supervision), approved by the Decision of the Customs Union Commission No. 317 of June 18, 2010, List of regulated products (goods, materials and commodities under quarantine), subject to quarantine and phytosanitary control (surveillance) at the customs boundary of the Customs Union and in the customs territory of the Customs Union; Approved by Decision No 318 of the Customs Union Commission of June 18, 2010, Agreement on common principles and rules of technical regulation in the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation; Agreement on circulation of products subject to mandatory assessment (confirmation) of conformity within the customs area of the Customs Union (December 11, 2009). 13 Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety; Regulation (EC) No. 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. These two documents are over-arching; further, Regulation (EC) No. 882/2004 together with a number of other regulations, establish specific food control procedures. 14 The intent is to ensure the protection of the customs territory of the Customs Union from the delivery and spread of infectious and mass noninfectious diseases (poisonings) among the population, by products (goods) not conforming to sanitary and epidemiological and hygienic requirements. To establish the procedures for import into the Customs Union area and the movement between the member states of products which are subject to the obligatory assessment (confirmation) of compliance. Finally, the intent is to protect the Customs Union from the importation and spreading of agents of infectious animal diseases, including those common to humans and animals, and goods (products) non-compliant with veterinary (veterinary and sanitary) requirements. 15 In addition food safety control is intended to guarantee fair practices as regards trade in food and feed and the protection of consumers’ interests, including labeling of food and feed and any other form of information intended for consumers. 16 Other than the Council and the Commission of the Customs Union (currently Eurasian Economic Union Commission), there are no supra- national bodies that are part of the control system. Comparative Analysis of Requirements and Arrangements of Food Control 13 between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union Enforcement is carried out by national bodies designat- and registering declarations of conformity by manufac- ed as competent authorities for specific areas of state turers or importers. Schemes of declaring conformity control (supervision), and also competent authorities in vary depending on the product, type of production (seri- the area of technical regulation. Conformity assessment al production of a single lot), the establishment that pro- is carried out by authorized certification (conformity duces the product and if the product is imported. While assessment) bodies that are listed in a single Customs each of the schemes for conformity assessment is dif- Union List; testing needed for the purposes of enforce- ferent they all contain several similar elements: creation ment is carried out by authorized testing laboratories as and analysis of technical documentation; in some cases well, and there is a separate Customs Union list of such carrying out of production control, testing of samples of laboratories. Because for several groups of products (e.g., food products, issuance and registration of a declaration specialized products, GMOs) state registration is required of conformity, and application of the unified mark of cir- (as one of the forms of assessment (confirmation) of culation on the market of the Customs Union. For some conformity), for registration of such products specially products, such as meat, one of the schemes also re- designated bodies are responsible. quires that the documentation submitted by the manu- facturer as evidences of conformity includes a certificate As mentioned, within the Customs Union foodstuffs are for the quality and safety management system (HACCP- subject to conformity assessment. The process of con- based) issued by the agency for certification of manage- formity assessment is carried out in the form of issuing ment systems17. Figure 3 Food Control System of the Customs Union Competent authorities in the area Approved Certification Bodies on registration of technical regulation (conformity assessment) of novel food Bodies Competent authorities Approved testing Bodies on registration in the area of state sanitary control laboratories of specialized food (supervision) Competent authorities Bodies on state registration in the area of state veterinary control of establishments (supervision) engaged in producing and processing of raw material of animal origin – meat, poultry, eggs, fish Competent authorities in the area of state phytosanitary control (supervision) Registers of: Approved certification bodies Uniform Lists: Approved testing laboratories products subject to mandatory assessment Specialized products (confirmation ) of conformity Novel food Goods subject to sanitary and epidemiological Establishments not subject to state registration surveillance (control) Establishments subject to state registration goods subject to veterinary control (engaged in producing and processing of raw material Goods subject to quarantine and phytosanitary of animal origin – meat, poultry, eggs, fish) control (surveillance) Establishments not subject to state registration Registered declarations of conformity Registered establishments in third countries (veterinary control) 17 This is specifically scheme 6 D as outlined in Customs Union technical regulation CU TR 034/2013 “On meat and meat products”. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 14 and the Customs Union of Russia, Belarus, and Kazakhstan In addition to conformity assessment, food products are Certain production/processing facilities have to be reg- subject to state control (supervision)18 which combines istered as well.21 This requirement extends to the facili- border controls (people, vehicles, goods) and internal ties engaged in production and processing of meat and controls in the member states. Food products are divid- meat products, milk and dairy products, poultry and ed into three groups that subject to respectively sanitary poultry products, and fish and fishery products. State (epidemiological, hygiene), veterinary, and phyto-sani- registration of production/processing facilities is con- tary control (supervision). The purpose of , for instance, ducted by the agencies authorized for this purpose by state sanitary (epidemiological, hygiene) control (super- the Customs Union member-states. This procedure be- vision) is to prevent the introduction and spread of, and gins with the application by the processor and is fol- to ensure the elimination of infectious and massive poi- lowed by an inspection of the facility to determine its sonings that are hazardous to human health, to prevent conformity to the requirements on processes (produc- occurrence of emergencies, as well as to prevent acts tion, processing, storage, transportation, sale, disposal) of terrorism with the use of biological agents, chemical established by relevant technical regulations. Details and radioactive substances19. of the procedure are established by the legislation of the Customs Union member-states. Upon satisfactory Certain specific products when first imported or pro- completion of the inspection and review of the find- duced in the Customs Union are subject to state regis- ings, the designated agency assigns an identification tration including: mineral, therapeutic, and bottled water; (record) number to the facility and adds the production beverages such as tonics and beer; food for special pur- facility in the Register of Food Facilities Subject to State poses, including food for babies and older children, food Registration. The state registration of a production/pro- for pregnant and nursing women; food additives, food- cessing facility has no expiration date; however it can be stuffs derived from genetically engineered or modified suspended or cancelled in case of serious breach of the (transgenic) organisms, and some food contact materi- requirements of technical regulations. als20. The fact whether such products have been regis- tered is verified during state control (supervision). Table 1 provides a summary of the state control (supervi- sion) framework within the Customs Union. 18 State sanitary control (supervision) is carried out against requirements to products and processes outlined in the Uniform Sanitary, Epidemiological and Hygiene Requirements over Products Subject to State Control (Supervision); State veterinary control is carried out according to Uniform Veterinary (Veterinary and Sanitary) Requirements for Goods Subject to Veterinary Inspection (Supervision). 19 Based on item 2-1 of Decision of the Customs Union Commission No. 299 of May 28, 2010 (with amendments to item 2-1 introduced by Decision No. 101 of the Eurasian Economic Council of July 7, 2014, the food products and items that are covered by the scope of certain technical regulations are exempt from the scope of Uniform Sanitary, Epidemiological and Hygiene Requirements. These include for example materials and articles produced of polymer and other materials intended for contact with food and food media, labeling requirements, food additives and flavorings, and technological aids, as well as meat and meat products, and milk and dairy products. 20 The goods from the list, manufactured for the first time on the Customs Union customs territory, as well as imported for the first time to the Customs Union customs territory, are subject to state registration (Part II, Single List of Goods Subject to Sanitary-and-Epidemiologic Supervision (control) at the Customs Border and on the Customs Territory of the Customs Union, as amended by Decision of the Customs Union Commission No 341 of 17.08.2010). 21 CU TR 021/2011 “On Safety of Food Products”, Article 31. Comparative Analysis of Requirements and Arrangements of Food Control 15 between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union Table 1 General Framework of the State Control (Supervision) in the Customs Union State Control (Supervision)22 Sanitary Veterinary Phytosanitary Customs Union Agreement on Agreement of the Customs Customs Union Agreement on Plant Key legal act Sanitary Measures23 Union on Veterinary and Sanitary Quarantine25 Measures24 Competent Competent Authorities in the area of state sanitary control (supervision) in member states authority Common list of goods subject Common list of goods subject to List of goods subject to quarantine to sanitary and epidemiological veterinary control and phytosanitary control control (supervision) (supervision)  Foodstuffs (products in natural  Live animals;  Vegetables, fresh or chilled; or processed form used  All food of animal origin, fresh  Dried leguminous vegetables; for human food) including and processed;  Fruits, fresh, dried; those derived from geneti-  Food that has ingredients of  Nuts, fresh or dried, whether or Scope cally engineered or modified animal origin; not shelled or peeled; (transgenic) organisms;  Yeasts, enzymes, starter  Coffee, not roasted, whether or  Materials, products and cultures; not decaffeinated; equipment contacting with  Grains and other plant origin  Cocoa beans; foodstuffs; items when they are intended  Grains;  Pesticides and agrochemicals for manufacture of feed  Cereal flours;  Seeds, whether or nor broken; Point of control At the border and within the customs territory of the Customs Union Documents Uniform sanitary, epidemiology Uniform veterinary requirements that establish and hygiene requirements for for goods subject to veterinary — compliance goods subject to veterinary control (supervision) criteria control (supervision) Procedure of state sanitary Procedure of carrying out List of Quarantine Products subject and epidemiological control veterinary control at the customs to quarantine and phytosanitary (supervision) over persons border and on the customs control (supervision) while being crossing the CU customs border, territory of the CU imported to the common customs goods subject to control that Procedure of carrying out joint territory of the CU are being moved through the inspections and sampling of Procedure of carrying out the customs border and customs goods (products) subject to quarantine and phytosanitary control territory of the CU veterinary control (supervision) (supervision) at the external border Procedural on the territory of the CU of the CU documents Common templates of product member states and third Procedure of carrying out the (goods) safety documentation countries quarantine and phytosanitary control Consolidated list of highly in respect of quarantine products dangerous and quarantine that are moved within the common diseases of animals customs territory of the CU Common templates of veterinary certificates (movement, import) Common register of state Register of food production Registers registration certificates for certain objects (facilities) that are subject to — products state registration 22 English translations as well as links to the specific documents referenced in the table can be found at http://ec.europa.eu/food/interna- tional/trade/sps_requirements_en.print.htm . 23 Decision No. 28 of 11 December 2009 of the Customs Union Commission, Decision No. 299 of 28 May 2010 of the Customs Union Commission. 24 Customs Union Agreement on veterinary and sanitary measures, Decision No. 317 of 18 June 2010 of the Customs Union Commission, as amended by Decision No. 342 of 17 August 2010, No. 455 of 18 November 2010, No. 569 and No. 570 of 2 March 2011, No. 623 of 7 April 2011, No. 724 of 22 June 2011 and No. 726 of 15 July 2011. 25 Decision of the Interstate Council of the Eurasian Economic Community No. 30 of 11 December 2009. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 16 and the Customs Union of Russia, Belarus, and Kazakhstan The organizational framework for the European Union is In the European Union, food control is organized in a quite different from that of the Customs Union in that at fashion that the uniform laws and regulations including the foundational level the European Union provides for those establishing procedures of routine control are ap- uniform, consistent food control procedures across all of plied throughout all member states. At the same time, its member states. In contrast to the Customs Union, the because this system is risk-based, member states have European Union does not rely on the laws, regulations a significant amount of independence in planning their or standards of member states to execute food control control activities. Verification of whether each member inside the member states. Even in the case of directives state properly applies the European Union food law is as one of the key legal instruments that require transposi- conducted through the Food and Veterinary office of tion into national laws, the level of uniformity is high be- DG SANCO26. FVO conducts audits in member states for cause directives set uniform objectives at a detailed level. compliance with requirements for competent authori- Further, within the European Union the responsibility for ties to ensure that each member state has the capac- food safety at all levels from primary production, trans- ity and capability to perform their role effectively and port, processing, storage and delivery to the consumer, impartially in accordance with the European Union including retail, catering, and restaurants is clearly placed requirements.27 The European Union establishes a uni- on food business operators. In this way the businesses form code of accreditation for laboratories28 including are responsible to ensure, through HACCP and HACCP- testing and sampling that is designed to ensure equiva- like systems, the safety of the products they produce, and lency and consistency of test results across the Member the role of the government is to ensure through monitor- States. In contrast the Customs Union relies on the ing and enforcement that the systems and practices are member states to accredit laboratories, and testing and effective and in compliance with the regulations. Figure sampling is conducted in accordance with the member 4 is a graphical representation of the food control system states laws, rules and standards. within the European Union. Figure 4 A Graphical Representation of the Food Control System in the European Union. European Commission Development of legal norms European Food Safety Authority (EFSA) FVO (Food and Veterinary Office Risk assessment/scientific of DG SANCO) support to legislators Second-line inspections of MS Rapid Alert System for Food Member States and Feed (RASFF) Enforcement, Sanctions Collection of information Community reference laboratories Business operators Reference testing Compliance/assurance of food safety 26 The EU Commission contributes to development of legal norms through adoption of implementing legal acts, and enforces feed and food law by checking that legislation has been properly incorporated into national law and implemented by all EU countries. This is done through on-the-spot inspections in the EU and is carried out by the Food & Veterinary Office (FVO) based at Grange in Ireland. The FVO may check individual food production plants, but its main task is to check that EU governments procedures in place for checking that their own food producers are compliant to the EU’s high food safety standards. The FVO also plays a key role in the development of EU policy in the food safety, veterinary and plant health sectors. 27 Criteria for National Competent Authorities, Regulation (EC) No. 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. The criteria include: legal/enforcement powers, management structure, independence, resources, personnel, recruitment and training. 28 Regulation (EC) No. 882/2004. Comparative Analysis of Requirements and Arrangements of Food Control 17 between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union The European Union does not establish procedures for or indirect risk to human health deriving from food registration of any foodstuffs similar to the Customs or feed. This network involves the Member States, the Union. However, it does establish procedures for au- Commission and EFSA. When a member of the network thorization of certain new substances (e.g., food ad- has any information relating to the existence of a seri- ditives and flavorings, dietary supplements), products ous direct or indirect risk to human health deriving from (novel food) and materials (food contact materials) when food or feed, the Commission under RASFF is immedi- those are developed and planned to be commercialized. ately notified, and the Commission then transmits this Authorization is done once for the product or substance, information immediately to the members of the net- and individual manufacturers do not have to register the work. Legal acts of the Customs Union provide for es- product or substance again. tablishment of a common Information System between the member states that would perform a similar func- As for individual food establishments, procedures of ap- tion, but this system has not been implemented so far. proval and registration apply. Establishments that oper- ate in a sector of animal origin food must be approved. It is important for governments and industry wishing Approval procedures include application by the food to export to either Union to understand the systems business operator, and documentary check and on-site of border control. Both the European Union and the inspection by an official inspector. As a result the facil- Customs Union have rigorous systems for border con- ity receives approval for operation and is assigned an trol which have some similarities but also differences. approval number that is added to a list of approved es- In both cases, a prior notice of the shipment must be tablishments. Facilities that operate in the non-animal submitted to the customs authorities29, border control food sector are required to register. This procedure does of foodstuffs consists of documentary checks, identity not involve on-site inspection, and means that a food checks and physical checks. Both Unions are guided by business operator must only submit information about the requirements and rules established by the OIE30 and the establishment to a competent authority. In fact, the IPPC31 when it comes to veterinary and phytosanitary European Union establishment approval procedure cor- issues at the border. responds to the Customs Union procedure of registra- tion of facilities. Both the Customs Union and the European Union have requirements related to pre-export approvals of the es- As the European Union is a risk-based food control sys- tablishments, in the exporting country for animal prod- tem, it includes two additional areas that do not exist ucts.. According to the Customs Union procedures, food in the Customs Union. First, the European Union estab- business operators in third countries who produce, pro- lished the European Food Safety Authority (EFSA) which cess and/or store food products under veterinary control provides scientific advice and scientific and technical (supervision) are subject to joint checks (inspections) by support (including substance and product risk assess- competent veterinary authorities of the Customs Union ments) for the Community’s legislation and policies in member states32. Establishments that passed the joint all fields which have a direct or indirect impact on food checks are added to the List of Establishments in Third and feed safety. This creates a uniform risk assessment Countries. In some cases, such checks (inspections) can process and advisory support to governments across be carried out by a competent veterinary authority of the member states of the European Union. Second, the only one member state; in other cases no checks are European Union has established Rapid Alert System on carried out, and an establishment can be added to the list Food and Feed (RASFF), for the notification of a direct without inspection. In the European Union, the scope of 29 Commission Regulation (EC) No. 136/2004 of 22 January 2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries (establishes a form of a Common Veterinary Entry Document (CVED)); Commission Regulation (EC) No. 669/2009 of 24 July 2009 implementing Regulation (EC) No. 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC. (establishes the form of Common Entry Document)/CED Decision of the Customs Union Commission No. 899 of December 9, 2011 “On introduction of compulsory prior notice on goods that enter the customs territory of the Customs Union by automobile vehicles” (establishes requirements to prior notice). 30 World Organization of Animal Health (Office International des Epizooties). 31 International Plant Protection Convention. 32 Procedure on Carrying-out Joint Checks of Objects and Sampling of Products that Subject to Veterinary Control (Supervision). Approved by Decision of the Customs Union Commission No. 317 of June 18, 2010. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 18 and the Customs Union of Russia, Belarus, and Kazakhstan pre-approval procedure is more extensive and it covers (those consisting of processed product of animal ori- pre-approval of establishments and also approval of the gin combined with plant material). As a general rule all countries. The pre-approvals of the countries are done food that contains a product of animal origin is covered by sector and the relevant lists of approved countries by veterinary checks unless it is specifically excluded34. and establishments are maintained by the Commission. In practice it means that all animal origin ingredients All inspections in the third countries are done by one in a composite foodstuff entering the European Union body – Food and Veterinary Office of DG SANCO. The shall come from approved countries and approved procedure of approval of third countries is very detailed establishments. and timely, and it includes a wide variety of require- ments to organization of food control system in a third As mentioned, in the Customs Union, all foodstuffs are country, as well as on-site inspections of third country divided into 3 groups: products that are subject to sani- establishments. At the same time, as soon as a third tary control (supervision), veterinary control (supervision) country is approved in general, the competent authority and phytosanitary control (supervision). In none of the in this country has the authority to approve establish- Customs Union member states is the food control sys- ments for export into the European Union. This means tem a single agency or has a clearly defined body that that for a food business operator wishing to export food would perform a coordination function; therefore, each of animal origin to European Union it may not become member state designates competent authorities in each possible until the country is approved. of the three areas, and they have shared responsibilities and roles in border control. Obviously, they cooperate The purpose of border control is to ensure that im- with the Customs bodies in their respective countries ported products meet regulatory requirements of the as well. For a potential exporter it means that they need target market. Thus, border control procedures in the to clearly define to which of the three categories the Customs Union and in the European Union reflect the product belongs to (whether it is an object of veterinary, specifics of their general food control systems. In the sanitary or phyto-sanitary control), and become familiar European Union, all foodstuffs for the purposes of all with details of each particular border control procedure. types of control including border control are divided into There are no specific requirements to composite prod- products of animal origin and products of plant origin; ucts or detailed rules of attributing foodstuffs to com- along with this, in many EU countries products of both posite products; all foodstuffs with ingredients of animal types are controlled by single authorities. Respectively, origin are subject to veterinary checks35. the first group is subject to veterinary checks (including aspects of hygiene and safety), and the other group is Another important difference is that both Unions require subject to phytosanitary checks (primary products) and that all consignments of food products be accompanied aspects of hygiene and safety. Since in European Union by a number of documents including a health certificate all member states have designated a competent author- or its analogue. However, because foodstuffs that are ity for the control of food safety33, in most cases it is a to be put into circulation at the customs territory of the responsibility of one body to ensure proper execution Customs Union have to pass conformity assessment of control of the imported food at the border. Obviously, (confirmation) procedures, in particular, by means of is- this body closely cooperates with the customs author- suance and registration of declaration of conformity with ity. Generally, animal origin foodstuffs are considered of technical regulations, a copy of such declaration or infor- higher risk to human health, and are controlled more mation about it36 shall be presented at the border as well. closely in comparison to plant origin products. While It should be noted that there is a certain disconnect in this approach is quite simple, special attention needs to the terminology used: technical regulations establish that be paid by potential importers to composite products conformity declaration is required for products that are 33 It does not mean though that all EU countries have a single agency food control system; in many cases, one agency performs only a coordination function. 34 Commission Regulation (EU) No. 28/2012 of 11 January 2012 laying down requirements for the certification for imports into and transit through the Union of certain composite products and amending Decision 2007/275/EC and Regulation (EC) No. 1162/2009. 35 Common List of Goods Subject to Veterinary Control (Supervision). Approved by the Decision of the Customs Union Commission No. 317 on June 18, 2010. 36 Information about declarations of conformity means that it is sufficient to present identification data (e.g., registration number), and then the fact it has been issued can be confirmed by checking the Customs Union list (e-based data-base) of registered declarations of conformity. Comparative Analysis of Requirements and Arrangements of Food Control 19 between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union to be “put into circulation”, while all customs regulations In summary, the main differences between the Customs and procedures say that presenting a copy of declaration Union and the European Union with regard to border of conformity or information about it is required when control procedures are in the following: product are “released for internal consumption”. There is  Scope of requirements to preliminary approvals: no definition for “putting into circulation,” and whether the European Union approves third countries for it is equivalent to “releasing for internal consumption” is foodstuffs of specific animal food sectors and unclear from the legal standpoint. At the same time, in individual food establishments; for this purpose, practice the two terms are interpreted as the same by the inspections in third countries are carried out by Customs Union, customs officials, and importers must DG SANCO Food and Veterinary Office (FVO). Unless a country is approved for certain sector, present their duly registered declarations of conformity at an establishment from this country cannot be the border. Declaration of conformity can be issued and approved to export to the European Union. On registered only if a product meets the requirements of all the other hand, as soon as a country is approved, applicable technical regulations. It means that, for exam- approval of establishments can be done by na- ple, in case of the fruit juice, it shall meet requirements of tional competent authority without FVO inspec- CU TR 005/2011 (safety of packaging), CU TR 021/2011 tions. The Customs Union does not approve third (general food safety), CU TR 022/2011 (labeling, entered countries; it only approves food establishments; into force in February 2015), CU TR 023/2011 (fruit and in most cases, this is done through joint inspec- vegetable juice products); and none can be omitted. tions of competent veterinary authorities of the Customs Union member states. As mentioned, in the Customs Union as well as in the  The Customs Union requires that duly registered European Union three types of controls are performed declaration of conformity (or information about at the border: documentary checks, identity checks, it) is presented together with other documents at the customs; no such requirement exists in the and physical checks; the former means taking samples European Union. and performing laboratory control. In the Customs Union while the customs procedures are risk-based,  The Customs Union does not define the frequen- cies of physical checks (or at least does not make the frequency of physical checks is not defined at the it public) whereas in the European Union, fre- all-union level (or is not made public), and in fact falls quencies are well defined and uniform through- under the national law of the member states. In the out the Community. European Union, frequency of physical checks is risk- based and depends upon several factors, including the Within any food control system, the business operators history of country of origin, the producer and the prod- play a crucial role in ensuring the safety of the food uct. Commission Decision 94/360/EC37 prescribes the that is produced and consumed. From production and level of physical checks for certain products. In general post-harvest handling, transportation and storage, to the minimum number of consignments to be subjected food processing operations and distribution, to retail, to a physical check are 20% for meat, meat products, catering, and restaurants all business operators have a fish, fishery products, 50% for poultry meat, honey, dairy role in ensuring the safety of food. The role the food in- products and shellfish, and at between 1% and 10% for dustry plays in food control and the way governments most products of animal origin that are not intended for apply food control to food business operators within human consumption. For certain products where there the food supply chain varies dramatically between the is a known health risk the European Commission may Customs Union and the European Union. For govern- prescribe a higher level of checking which may include ments wishing to model or harmonize with one or the compulsory sampling. Regulation (EC) No. 669/2006 other Union’s food control system, it is important to establishes a list of foodstuffs of non-animal origin (e.g., understand the overall approach and the details of the frozen strawberries, peanuts, dried apricots, tea, etc.) requirements to food operators/businesses across the from specific countries and frequencies for identity and supply chain. physical checks that vary from 10% to 50%38. 37 Commission Decision 94/360/EC of 20 May 1994 on the reduced frequency of physical checks of consignments of certain products to be implemented from third countries, under Council Directive 90/675/EEC. 38 Commission Regulation (EC) No. 669/2009 of 24 July 2009 implementing Regulation (EC) No. 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 20 and the Customs Union of Russia, Belarus, and Kazakhstan To explain the differences in requirements to food busi- do not have to implement HACCP, instead they shall ob- ness operators, we need to go back to the intent and the serve good hygiene practices; all the rest of the food scope of food legislation in both Unions as those have business operators, whether they are manufacturers or a material impact on the requirements to food business not, must put in place, implement and maintain proce- operators. The intent of food control at a high level is the dures based on HACCP principles. The fourth important same within both Unions: to ensure the health and well- aspect is that in many cases due to the limitations of being of consumers, prevention of practices misleading segregation within the food supply chain it is impos- consumers (adulteration or fraud) and environmental sible to separate food from feed (for example grains) and protection. The European Union extends the intent of therefore both must be controlled. the food laws to include an integrated risk based ap- proach “from farm-to-fork” related to food and feed In the Customs Union conformity assessment and products and establishes primary legal liability and re- therefore food control is limited to a narrower group of sponsibility of food business operators for food safety39. entities and persons: manufacturers, sellers and persons (entities) who represent foreign food manufacturers41. This extension of the intent is significant to understand- Their main responsibility is to ensure that their products ing of differences between the Customs Union and meet the requirements of the technical regulations, and European Union with regard to requirements on food only food manufacturers are required to implement pro- business operators. First, the European Union recog- cedures based on HACCP principles. Therefore, it is as- nizes that risks need to be mitigated and controlled sumed that conformity to technical regulations means throughout the food chain from farm-to-fork. For the that the food is safe. This places a much higher respon- European Union this establishes the integrated role of sibility in ensuring food safety on the developers of the the food chain and the fact that hazards can come from technical regulations and on food control bodies who all levels in the supply chain and therefore must be con- must, by establishing specifications, providing laboratory trolled across the entire food chain. Second (which de- services, registering declarations of conformity and car- rives from the previous statement), the food law applies rying out control (supervision) confirm that during the to all food business operators (those carrying out activi- period of validity of the declarations the product is safe ties related to any stage of production, processing or dis- and complies with specifications. No doubt the manu- tribution of food from primary production through sale facturer has a significant role in ensuring the safety of of the good to the consumer)40. Third, food business food, but it is not as large and clearly defined as in the operators have the primary responsibility for food safety. European Union. Obviously, the model of declarations This is not meant to imply there is not a role for govern- of conformity place a larger responsibility on manu- ment: the government has a major role in food con- facturers compared to the certification model, but still trol including setting laws, monitoring compliance and it does not have the same level of responsibility as in determining the effectiveness of food control measures the European Union. Finally, in the Customs Union the and enforcement activities. Putting the prime responsi- technical regulations only apply to food, not feed. bility on the food business operators is the recognition that food safety can best be controlled first and foremost Within the scopes of the regulatory framework of the by the food business operators who produce, transport, Customs Union and the European Union there are two process, distribute and sell the food products intended other topics related to food operators that need to be for consumers. The only difference between the food considered. The first is flexibility as an approach to im- business operators in terms of the scope of require- plementation of the legal requirements, and the second ments is made between those involved in production of is the breadth of the requirements. In the Customs Union primary products, and those who operate non-primary the technical regulations and rules are applied equally products: food business operators in primary production to all operators regardless of size or the volumes of 39 Regulation (EC) No. 852/2004 on the hygiene of foodstuffs. 40 According to the EU law, “food business operator” means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control; “food business” means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food (Article 3, Regulation (EU) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety). 41 CU TR 021/2011 “On safety of food products”, Article 10. Comparative Analysis of Requirements and Arrangements of Food Control 21 between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union products produced, and irrespective to production using With regards to HACCP, both Unions use this term and traditional methods (e.g., traditional cheeses). Because have the 7 principles of HACCP outlined in the respec- of the breadth and coverage of the European Union tive legal acts, 43 but the interpretations are different. This regulatory framework as well as the intent to allow for has an impact on how HACCP is used as a tool to en- the production of traditional products as a means to in- sure the safety of food stuffs with respect to business crease incomes especially in rural areas, the European operators. These differences include: Union incorporates flexibility within its food control sys-  In the Customs Union, HACCP requirements are tem. While the application of systems based on HACCP only applied to manufacturers whereas in the principles is required at all levels of the food chain (with European Union HACCP requirements are ap- exception of primary production), the European Union plied to all levels of the food supply chain after recognizes that it is possible to give smaller enterprises the primary production (including, but not limit- flexibility on how the HACCP principles are applied. The ing to, processing, warehousing, transportation, retail, catering, cafes and restaurants). European Union ensures that controls are effective but does not place undue burden on smaller food business  The Customs Union limits the identification of hazards (HACCP Principle 1) to those during operators or eliminate the use of traditional food pro- the process of production (manufacture) that cessing methods. In addition, the European Union rec- can lead to the release into circulation of non- ognizes that with respect to food hygiene, at some food conforming products (non-conforming with the chain levels not all of the requirements can be applied requirements of technical regulations (including in full or can only be applied with certain limitations42. those unrelated to hygiene such as organolep- tic)). In the European Union food business opera- The Customs Union technical regulations include a sig- tors are required to only identify any significant nificant number of specific provisions and requirements food safety hazards, including those that are not with respect to processes of production, processing, specified in the regulations. transportation and so on. In many cases, they are quite  In the identification of critical control points detailed and prescriptive. As a reflection of the overall (CCPs, HACCP Principle 2) the Customs Union legal framework, they are a combination of general re- focuses on the identification of specific param- quirements (applicable to all foodstuffs) and product- eters which are to be controlled in order to pre- specific requirements (where those exist, including food vent or eliminate hazards. In the European Union CCPs are not parameters but rather process steps of both plant origin (oils, juice products) and animal ori- at which control is essential to prevent or elimi- gin (fats, meat, milk and dairy), plus specialized foodstuffs nate a hazard or to reduce it to acceptable lev- that can be both plant and animal origin. In addition, in els. The European Union recognizes that it is not the near future when relevant new technical regulations possible to eliminate all hazards but instead con- will be adopted, there will be product-specific require- trol these to such a level that they no longer pose ments to processes related to poultry products, fish- a threat to human health whereas the Customs ery products and mineral waters. These requirements Union specifically states to eliminate hazards. do not always relate to safety or hygiene; for example,  With respect to verifying the effectiveness of the some are on sizes. In the European Union a different controls (HACCP Principle 6), the Customs Union approach is applied: the requirements to processes of establishes that verification must be done in the production, processing, transportation, retail are related form of testing the final product against require- only to food hygiene; they include general and prod- ments of relevant technical regulations, and this uct-specific hygiene practices, and the product-specific is the only verification activity mentioned. In the European Union the food business operator is ones are focused on all sectors of animal origin. At this required to establish procedures, which shall be level of requirements, there are many similarities be- carried out regularly, to verify that the control tween the two Unions, but also the differences are quite measures are working effectively. This implies numerous (e.g., with regard to physical structures, tem- various verification activities, like validation of perature regimes, timing of certain operations). critical limits, review of records, revision of the HACCP plan as needed, testing against process 42 EU Guidelines on implementation of certain provisions of Regulation (EC) No 852/2004. 43 In the EU – Article 5 of Regulation (EC) No. 852/2004 ; in the Customs Union – Articles 10 and 11 of CU TR 021/2011 “On safety of food products”. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 22 and the Customs Union of Russia, Belarus, and Kazakhstan hygiene criteria, and, as one of many activi- ties, testing of the final product against the legal criteria.  With respect to documentation (HACCP Principle 7) the Customs Union focuses on maintain- ing documents that prove that specific activities were performed, whereas in the European Union documents and records must be established and maintained to demonstrate the effectiveness of the HACCP system.  Within the Customs Union there is no require- ment for the training of the personnel of food establishments on issues of food hygiene and implementation of HACCP principles which is a requirement in the European Union.44 Traceability is a way of responding to potential risks that can arise in food and feed. It is vital that when national Traceability in Action authorities or food businesses identify a risk they can trace the cause of the risk back to its source in order In autumn 2004, during standard to swiftly isolate the problem and prevent contaminated random monitoring of dioxin levels in products from reaching consumers. In addition, trace- milk at a Dutch farm, national compe- ability is meant to ensure that targeted and accurate tent authorities found a high level of withdrawals or recalls can be undertaken, appropriate dioxin. They immediately barred the information can be given to consumers and food busi- farm from trade, and initiated the trac- ness operators. Traceability also enables the government ing of the product through the food to perform a risk assessment to prevent unnecessary chain. This revealed that the source wider disruption of trade. As such, traceability does not of contamination was clay, used in itself make food safe. It is a risk management tool to be food processing to separate high qual- used in order to assist in mitigating through contain- ity potatoes from lower quality ones. ment a food safety problem. While both Unions45 require Potato peels from a restaurant chain to some extent traceability there are some differences were supplied to the farm and used to between the requirements that impact food operators as feed animals. The hazard several times well as the overall function of a traceability system. The moved from food chain to feed chain traceability requirements in the Customs Union are lim- and back. It was quickly established ited to food products and raw food materials. This can that the clay had also been supplied create a significant gap in the traceability system as this to several food processing companies does not include feed, food-producing animals or sub- located in the Netherlands, Belgium, stances intended to be or expected to be incorporated France and Germany. Appropriate ac- into a food or feed product. The Customs Union limits tions were swiftly taken. traceability requirements to food products and requires only the manufacturer and subsequent proprietors to maintain the records and have a system of identifica- tion of products for the purpose of traceability with the help of marking. This excludes tracing back from the manufacturer and limits the ability of the government to understand the source of the problem and ensure the timely withdrawal and notification of consumers as to 44 Regulation (ЕС) No. 852/2004, Chapter XII “Training”. 45 In the European Union – Regulation (EC) No. 178/2002; in the Customs Union – technical regulation CU TR 021/2011. Comparative Analysis of Requirements and Arrangements of Food Control 23 between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union the risk posed by the event, as the complete food chain and outcoming products, and that they have a system is not included. The European Union requires that food of identification of products for the purpose of trace- business operators at all levels of the food chain have a ability with the help of marking. By having a system that traceability system, that they maintain the records allow- encompasses the complete food chain the European ing to trace back and track forward incoming materials Union has the ability to trace the source of the problem. Important Notes for Governments, Policy Makers and Businesses While the intent of food control at a high level is the system, and the European Union as an outgrowth of a same for the European Union and the Customs Union consumer driven economy. All this is reflected in the of Russia, Belarus and Kazakhstan, which is to ensure manner of how the regulatory environment is arranged the health and well-being of consumers, prevention in each Union, including in the area of food control. The of practices misleading consumers and environmental Customs Union food control system is based on estab- protection, there are significant differences between the lishing food safety through conformity assessment of two Unions. The dissimilarities include: the final product. In this system the final food product  the fundamentals of the regulatory instruments is deemed safe when it conforms to specific Customs and fundamental approaches to food safety and Union technical regulations, or recognized voluntary types and power of legal instruments that regu- standards, and/or member state laws and regulations. late it; The European Union’s approach is to have a preventive  organizational arrangements; food control program across all member states found-  the specifics concerning the scope of legal acts, ed on the principle of risk assessment and mitigation the implementation and methods of execution; from farm-to-fork. This is not to imply that one system and is better or worse in providing safe food to consumers.  the role of food business operators and the re- Instead this statement is designed to explain why there quirements for food business operators within are differences between the two Unions with respect to the food control system. food control. In fact the two systems are so divergent that simultane- In general, the Customs Union adopted an approach to ous harmonization with the two Unions becomes im- technical regulation that is very similar to the one used possible. Further, from a legal perspective, the differences in the European Union (the so called “new European between the Unions are great enough that if a country Union approach to technical harmonization and stan- or a business harmonizes with either of the Unions, they dards”46) for a wide range of consumer goods and indus- will be able to meet the requirements of the food control trial items (toys, cosmetics, electric equipment, elevators, system of the other only by creating two parallel or dual high-pressure vessels, and many others). However, there control mechanisms. In real life, because many of the is a significant difference: in the European Union, food Customs Union provisions on food have not yet been is NOT an area covered by technical harmonization fully implemented, it is difficult to judge about how they within the “new approach”, and all the features of this will work in practice. approach are not applicable to control of food safety. In the Customs Union, technical regulation as an approach Fundamental approaches: To start with, the man- to control of safety has been extended to foodstuffs as dates of the Customs Union and the European Union well, and this is at a foundational level why the two sys- as unions of states differ as the European Union cov- tems diverge significantly. ers a much broader range of areas of common policies. The level of integration is much higher in the European Types and power of legal instruments: The European Union as well. Both Unions have their own historical Union uses three main types of legal instruments – reg- and cultural backgrounds with the Customs Union be- ulations, directives and decisions. Regulations are legal ing adapted from the Soviet control and standardization acts that are directly applicable in member states, have 46 Council Resolution 85/C 136/01 of 7 May 1985 on a new approach to technical harmonization and standards. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 24 and the Customs Union of Russia, Belarus, and Kazakhstan the power of laws and supersede national laws; they key legal aspects are covered by all-union provisions incorporate implementation mechanisms. Directives es- and are uniform in their objectives and implementa- tablish objectives that are compulsory to member states, tion procedures, in the Customs Union there is always a but require transposition into national law as they do not need to also identify a range of applicable national laws include implementation mechanisms. Decisions can be and regulations of member states, as procedural details addressed to both member states and specific entities; are covered by those and may vary from member state they are directly applicable but usually cover a narrow to a member state. topic or issue. In recent years, the European Union has moved to the control of food safety through regulations From the institutional perspective, there are substan- (not directives, as earlier); all the most important aspects tial differences between the two Unions as well: in the of food control are regulated through regulations thus European Union there are several supra-national bod- creating a high level of harmonization and uniformity ies and agencies that actively participate in shaping, im- in the member states. In the Customs Union, the main plementing and supervising policies in the food safety legal instrument used is technical regulations; there also area, for example, European Union Commission and its are standards (voluntary, but de-facto mandatory when Directorate General SANCO and the Food and Veterinary they establish methods of sampling and testing), proce- Office (FVO), as well as the European Food Safety Agency dures (established by decisions), and requirements. They (EFSA). Further, there is a competent authority in each all are directly applicable in the member states (activities member state that is responsible for food safety con- in the area of technical regulation and conformity as- trol; even in countries where institutional framework is sessment), but with some exceptions they do not incor- more complicated than a single agency model, there is porate implementation mechanisms – those can only one agency that bears a single responsibility in the food be found in the Customs Union member-states national safety area for the purposes of the European Union poli- laws and regulations. Technical regulations while direct- cies (a “single window” to be contacted by other gov- ly applicable are focused mostly on technical aspects ernments and businesses). In the Customs Union, while of products and establish specifications, not policies. It the Commission of the Customs Union sets policies, is important to understand the differences between the there are no bodies that would execute implementation legal acts as they help to identify the areas where pos- or provide supervisory roles. The institutional framework sible differences may exist between the member states is based on a system of national bodies each designated of each Union. as responsible for a particular role (e.g., responsible for sanitary control, veterinary control, phyto-sanitary con- Organizational arrangements: The legal framework trol, technical regulation, certification and conformity of the Customs Union combines horizontal legal acts assessment, registration of specialized food, registration and vertical legal acts. There are several technical regu- of novel food, and so on). This supports a “specialization” lations (on general food safety, labeling, packaging, food within the Customs Union of the existing food control additives and flavorings) that cover cross-cutting aspects bodies in the member states, and does not burden the for all food products (it should be noted though that the member states with the need of institutional reform, technical regulation on packaging also covers packag- even though one body can be designed for more than ing for non-food items). There are plans to develop a one role. Therefore governments and businesses need technical regulation on food contact materials that to remember that in the Customs Union member states would have a horizontal nature as well. There are also there is no “single window” on food control issues. The a growing number of vertical technical regulations that best approach would be to first check on the official are specific to certain product groups, in particular grain, Customs Union website (http://www.eurasiancommis- oils and fats, fruit and vegetable juices, meat and meat sion.org/) to determine which body in the target country products, milk and dairy products; several more are be- of export is designated responsible for a specific activity. ing drafted (on alcoholic products, poultry and poultry products, fish and fishery products, and mineral water). Specifics concerning the scope of legal acts, spe- In contrast the current legal framework of the European cific provisions and implementation: In most cases Union in the food area is mainly based on horizontal the corresponding legal acts or their parts in force in the legal acts, and is moving to even stronger horizontal European Union and the Customs Union have differ- organization. For governments and businesses in third ences in scope; sometimes this is due to differences in countries it means that while in the European Union all key definitions, in other cases there are differences in Comparative Analysis of Requirements and Arrangements of Food Control 25 between the Customs Union of Russia, Belarus, and Kazakhstan and the European Union subject areas and/or activities covered. In general, the not require country approvals: instead, approvals European Union legal acts encompass a greater num- are required only for individual establishments ber of areas and specific issues relative to the Customs that produce/process several types of food of an- imal origin. The approvals are granted after a joint Union’s. However, businesses should keep in mind that inspection by representatives of veterinary com- it does not necessarily mean that when there is no re- petent authorities of the Customs Union member quirement in the Customs Union technical regulations, states, or without on-site inspections. the area or specific issue is not regulated at all. In most  At the border, control procedures of foodstuffs cases it is likely that there are applicable national norms are similar in many respects, however differences of the Customs Union member states, and it is impor- still exist. With regard to physical checks of con- tant to identify these and comply. Further with reference signments (testing of samples) in the European to legal acts, there is another important feature that is Union the percentage to be sampled is well de- different: the European Union legal acts are addressed to fined and published in the European Union. In member states (and, first of all, their competent authori- the Customs Union it is unclear as to when and ties) and food business operators in a broad meaning how often a product will undergo checks and of this term, while the Customs Union technical regula- therefore for exporters the chances that specific tions either do not clearly identify addressees of some products or shipments will undergo a physical provisions, or identify manufacturers, sellers and import- check is not defined. ers as the addresses. Role and requirements of food business operators: There are multiple differences on specific legal provi- Like with other areas, there are similarities and differ- sions related to organization of food control. For gov- ences between the requirements and procedures that a ernments and businesses in a third country the most food business operator shall conduct to ensure that his noteworthy are the following four: food is safe. The differences range from procedures of  In the European Union it is required by law that registration of approval, hygiene requirements, tempera- member states develop national annual and ture control and duration of processes, to provisions of multi-annual control plans that are submitted to the HACCP system. While both the European Union and the Commission. This, as well as the Rapid Alert the Customs Union require development and imple- System for Food and Feed allows for implemen- mentation of procedures based on HACCP principles, in tation of the risk-based approach. There are no the European Union this requirement is addressed to all similar provisions in the Customs Union, and its food business operators throughout the food chain, and legal acts do not provide for any mechanism for in the Customs Union only manufacturers are required sharing control plans and results between the to comply. member states, or for developing a common short-term or mid-term policy. There are differences in interpretation of several HACCP  It is a common practice within the European Union to conduct audits by VFO of competent principles: on hazard analysis, critical control points, ver- authorities in member states to determine the ca- ification and record-keeping, and the Customs Union pability and capacity to implement the European interpretation is narrower than that of the European Union regulatory requirements. There are no Union. Importantly, HACCP systems at third country similar arrangements that exist in the Customs establishments are checked as part of the company Union. approval audits. This is a significant difference for food  With regard to imported food for all groups of businesses operators as HACCP systems cannot be built animal origin, the European Union requires two- or re-built overnight. Therefore food business operators level approvals: approval of a third country (by wishing to export to either market must be aware of the animal food sectors) and approval of each indi- specific HACCP requirements in each Union and be vidual establishment from which food is exported ready to address them. to the European Union. The Customs Union does Comparative Analysis of Certain Requirements of Food Legislation in the European Union 26 and the Customs Union of Russia, Belarus, and Kazakhstan Requirements to Food Quality in the European Union and the Customs Union product quality attributes are static, constant and almost never changing. These options are not mutually exclu- sive and are found intertwined between government policy, laws and regulations and industry standards globally across many industries including food and ag- ricultural products. Executive Summary In order to try to satisfy the implied and evolving con- Quality is a term that is used frequently by governments, sumer needs governments and industry expend enor- policy makers, industry, and consumers to describe mous efforts into studying consumer preferences and products and services. It is a descriptor whose defini- change their products accordingly. This increases com- tion is influenced by culture, attitudes, expectations, and petition and the number of product variations offered to stated and unstated needs. Historically, quality has been consumers, and the market grows quickly. For example in primarily understood as the absence of defect, fraud and the food industry thousands of new products are offered adulteration1. More recently with the global acceptance annually ranging from new varieties of tomatoes, differ- of the private standard ISO 9000, quality is defined with- ent production methods, organic/bio, to new products in the business community and by governments as the designed to meet the growing variation in buyers. As the totality of characteristics of an entity (product, service, number and variety of food products grow, it becomes process, activity, system, organization, and person) that unrealistic for governments and policy makers to regu- bear on its ability to satisfy stated and implied needs2. late all their quality attributes through laws, specific stan- Within the definition of quality as it relates to goods in- dards, and enforcement actions. Therefore, governments cluding food there are two key points that need to be attempt only to regulate the key characteristics – those emphasized: quality is a combination of product charac- that relate to health (safety), leaving the remainder of the teristics, and these characteristics must meet consumer attributes to be defined and set by the market place. needs, both states and implied. An alternative is where the industry and governments Product characteristics include physical attributes such dictate consumer needs through regulation and techni- as shape, size, and weight. For food additional attributes cal standards. In this situation governments and industry of appearance, colour, smell, taste, packaging, and even influence the consumer in such a way that the products freshness further define quality. Quality attributes are de- become static and therefore predictable. The outcome signed to satisfy the needs of consumers. Yet consum- of this is a relatively small number of products offered ers have stated and implied needs that make defining to the consumer. The products that are offered are in- quality challenging. Consumer needs and preferences dependent of manufacturer as they have same uniform are influenced by culture, media, personal taste and characteristics and are always the same everywhere. habits, and economic background and therefore are This strategy does not promote competition but instead not homogeneous nor are they static. Consumer needs facilitates a high level of standardization and allows for change overtime and therefore in order to meet con- long-term planning by governments and industry. The sumer stated and implied needs product characteristics products do not evolve and over time their uniformity or attributes change as well. becomes an attribute that consumers expect and there- fore define the products attributes. Further, since there is In order to satisfy the consumers’ ever changing needs no market influence and all product characteristics are and therefore changing definition of quality, two com- firmly established, it becomes possible for the govern- mon paths are followed by governments and industry. ment to set laws and technical specifications that define One path is where industry and governments study the uniform quality of a product. consumers and create new products to meet consumer needs. Alternatively, the other path is where industry and While quite different in outcomes both models and hy- government set consumer preferences and therefore brids of such models exist today across the world and 1 Food and health in Europe. WHO publication, 2004. 2 ISO 9000:2000. Quality Management Systems. Fundamentals and Vocabulary. Since we look at the term “quality” in a historical context, we use an old version of ISO 9000 (of 2002); currently the version ISO 9000:2005 is in force. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 28 and the Customs Union of Russia, Belarus, and Kazakhstan incorporate many consumer products, as well as agri-  The next level need is reliable, on-going access cultural products and foodstuffs. to food. People who feel reasonably assured that an adequate amount of familiar and acceptable food is currently available can plan for subse- At the foundational level, differentiation of products is quent meals, accumulate food, and budget for determined by consumer needs and purchasing power. food purchases. At this level, food shelf-life be- Trade-offs are made by consumers based on income, comes important. and these trade-offs define product size, quantity and  Good tasting food – once food security and attributes including quality. What may be acceptable to the consistent availability of food are adequately one economic group may not be affordable, acceptable addressed, appetite again becomes salient, and or desired by another. food choices are influenced by aesthetic and gastronomic considerations. People select food The food needs of consumers in relation to each oth- that tastes better to their individual taste. New er exist in a hierarchy. According to hierarchy of food quality attributes are added, like palatability and needs developed by Ellyn Satter3 based on the famous improved organoleptics and in general, availabil- Maslows hierarchy of needs, most common food needs ity of different taste options of core food. are as follows (from basic to highest):  Novel food – at this level on the hierarchy, the  The basic need is getting enough to eat; at the prospect of wasting unappealing food is less starvation level quality does not matter; what risky, and experimenting with novel food be- matters is whether the food is available, and comes a possibility. Novel food is not just a new whether it is filling and sustaining; food; it is food that is produced using technolo- gies or ingredients that have never been used be-  The next level of food needs is the ability to ac- fore, so tasting becomes an adventure in a way. quire acceptable foods in socially acceptable Preferences change based on new experiences, ways. “Acceptability” is highly subjective and may and consumers seek for new quality attributes. relate to certain quality factors, e.g. nutritional quality, acceptable appearance, as well as social  Instrumental food – the person functioning at norms about food selection and manner of food the apex of the hierarchy is in a position to con- acquisition. People usually identify the so called sider choosing food for self-actualization and for core food items that they eat most often and call instrumental reasons, like to achieve a desired them regular or common. physical, cognitive, or spiritual outcome, or to Figure 1 Satter’s Hierarchy of Food Needs Instrumental Food Quality attributes become important Novel Food Good-Tasting-Food Reliable and On-going Access to Food Acceptable Food Enough Food 3 GEM NO. 447 Hierarchy of Food Needs, Ellyn Satter, Ellyn Satter Associates, Madison, Wisconsin ( J Nutr Educ. Behav. 2007;39:S187-S188. Requirements to Food Quality in the European Union and the Customs Union 29 demonstrate their attitude to certain events or developed where a limited set of attributes regulate food phenomena. These instrumental reasons may safety. Across the world it is common to find a mixture or may not be rational or supported by scientific of both regulatory approaches that combine horizontal inquiry. An example would be eating - or avoid- and product specific (vertical) regulatory environments ing - certain food items to resist disease, prolong related to food safety and food quality. This hybridiza- life, or enhance mental and emotional function- tion arises from historical context, cultural differences, ing. At this point people are looking for totally new quality attributes related, for example, to in- as well as governments and industry needs to provide creased convenience, specific nutritional prop- consumer protection especially in high risk areas such erties, forms of production, production areas, as baby food, and food for special medical purposes. specific production methods or techniques. In the case of the Customs Union and the European This range of food needs present challenges and oppor- Union both groups use a combination of broad regu- tunities for industry and governments. For governments lations and product specific regulations to ensure the and industry where food quality attributes are primarily safety of food within their economic blocks. Having determined by industry and market place each compa- said this, the Customs Union member states predomi- ny will have a unique strategy for attracting consumers nantly control food safety and quality attributes through focused on meeting their specific and implied needs. a significant set of Union and National product specific This leads to competition and creativity in the market technical regulations. The focus of these regulations is place creating new food products for consumers at all to ensure food safety and to clearly define, regulate and buying levels. Governments wishing to define and set enforce a harmonised set of technical specifications for specific standards will have to develop hundreds if not every food product introduced to the Customs Union. In thousands of standards and technical regulations across contrast, the European Union has taken a different ap- a range of products. While this may create a degree of proach where quality attributes are defined by industry stability within the market place it increases the burden to meet consumers’ needs and only regulates and en- for the government. forces food safety primarily through a series of horizon- tal regulations. Therefore in the European Union food A key food attribute is food safety. Food safety is a pri- safety is separated from food quality and specifically mary attribute of all food as unsafe food is unacceptable regulated. at all levels of food needs and economic purchasing power. Globally two different approaches to food safety In order to understand the food quality and safety have been taken. Where food safety is determined to be regulatory frameworks of the Customs Union and the the most important food attribute, governments have European Union it is important to understand the his- developed specific regulatory frameworks establishing torical basis from which these two different mecha- food safety as a primary regulatory regime. This regu- nisms originated. The Customs Union and the European latory regime establishes a finite set of horizontal laws Union evolved differently and were developed to meet and regulations that cover all products. Alternatively, very different policy, industry and consumer needs. Both where food safety is included as just one of the product evolved through many decades and while both met the specific attributes and is regulated as such, a significant needs of society both approached meeting these needs number of product specific technical regulations are quite differently. Historical Context Customs Union the Soviet Union. The economy was based on 5-year When the devastating consequences of the WWII were planning cycles, and under a 5-year planning system overcome, the three basic food needs (sufficiency of it was unrealistic and impossible to quickly change the food, acceptability and ongoing access) were satisfied in foodstuffs production to adjust it to potentially chang- the Soviet Union. A cornerstone of the Soviet economy ing consumer preferences. Further the central planning was central planning which was designed to provide system dictated a high level of standardization and uni- sufficient products across all 15 republics that comprised formity across all 15 republics. To balance the needs of Comparative Analysis of Certain Requirements of Food Legislation in the European Union 30 and the Customs Union of Russia, Belarus, and Kazakhstan a centralized economy and that of the consumers the Soviet system influenced and specified consumer needs through a set of unified products based on harmonized central standards (GOST). The high degree of uniformity helped to satisfy another food need – the need for good taste (and other organoleptics), because consumers ac- quired a habit to certain uniform tastes of core products. Also, because of rather high social standards, standard- ization helped to satisfy partially the highest need of the hierarchy of food needs – the need in instrumental food, in particular, where it concerned such quality attributes as special nutritive properties for specific health condi- tions (medical purposes, special diets, vulnerable groups of population, e.g. children). GOST 4.29-71 “Quality rating system. Canned meats, meats- As standardization was a cornerstone of the Soviet vegetable. Quality characteristics economy therefore spending significant resources on nomenclature”. developing and enforcing standards was justified and applied to all products including the standardization Establishes the following quality of food. For each group of products, a separate GOST characteristics: Standard existed that established a system of quality cri- a) General (applicable to all canned teria and a nomenclature of specific parameters used meat/vegetables): to evaluate quality, including, but not limited to, such  Appearance, quality attributes as organoleptic, presence of chemicals,  Presence of connecting tissues microbiological condition, shelf-life, storage conditions,  Odor and taste solid/liquid phase ratio, moisture content, fat, protein,  Color sugar, salt, starch and other similar characteristics as  Texture applicable to different types of foodstuffs. Many other GOST standards supported each ingredient and each  Ratio of meat phase, bones and production step. liquid phase  Physical and chemical proper- With the independence of the 15 republics the con- ties: salt, tint, plumbum, shelf life and storage conditions, cept of food quality and safety control did not change microbiological parameters. much in that food quality and safety are defined through new laws and a series of product specific technical b) Additional (applicable to certain regulations and state standards. The economies of the product groups): % fat, % moisture, Customs Union have the basic philosophy that food and % starch, sodium nitrite, copper, jelly food safety are best controlled through a body of several melting T, pH. horizontal and multiple vertical legal acts for groups of foodstuffs. The principles of technical regulation in the Customs Union require that common legal acts for each food category sold in the Customs Union shall be devel- oped. This will include all products attributes including those related to food safety and food quality. European Union With the development of the European economy post WWII, the three basic food needs (sufficiency, accept- ability and on-going access to food) were satisfied as Requirements to Food Quality in the European Union and the Customs Union 31 well. In the early stage of existence of the European emphasis shifted from product-specific, vertical (prod- Economic Community (late 1950’s - early 1960’s), mem- uct composition) legislation, to horizontal legislation, ber states had thousands of national product standards. meaning general rules addressing common aspects for Those standards regulated such aspects of quality as, for all foodstuffs, or at least for as many products as pos- example, food composition. To ensure real free move- sible4. Over time the focus of the legal enforcement ment of goods through national boundaries, European moved to food safety and most of the quality charac- Community legislators at first attempted to harmonize teristics of food were left, with certain exceptions, to the the food standards. However, since all European Union free market to regulate. Therefore in the European Union norms have to be approved by unanimous vote on with the development of demand-driven food sector, one hand, and thousands of foodstuffs throughout the the European food control system does not attempt to Community were already offered, creating a harmo- regulate those product characteristics (quality) that are nized document for each of them was soon recognized supposed to be flexible to meet consumer preferences. as impossible. Through case law and decisions of the Instead the European Union regulators and policy mak- European Court of Justice, a general rule was intro- ers focus only on two areas: food safety where there is duced: products that have been lawfully produced and a health concern and where specific consumer interests marketed in one of the member states may not be kept must be specially protected because otherwise either a out of other member states on the grounds that they high potential of fraud is possible, or an informed choice do not comply with the national rules. Therefore the by consumers cannot be made. Determining the Criteria and Scope of the Comparative Analysis of the EU and CU Requirements Related to Food Quality For the purposes of this legal analysis the scope of food (organoleptics/size and shape). While three areas are quality is limited to a range of food attributes and charac- common, the range of products covered is wide in the teristics other than those related to food safety, and that Customs Union, and narrow in the European Union. are expected to be found in the product by consumers5. While the European Union does not regulate food quality In addition to these “common” quality characteristics each in general there is a small number of selected foodstuffs Union has other specific areas that are covered. In par- for which legal acts regulate specific product character- ticular, the Customs Union member states through their istics that can be attributed to food quality. To enable the technical regulations and state standards regulate product comparison we call such product characteristics “food stability (shelf-life and packaging)6. There are no similar quality characteristics” even though they are not called regulations within the European Union, and food busi- as such in the European Union legal acts. In the Customs ness operators establish shelf-life through risk-based re- Union, requirements on certain quality characteristics search for each product, with account to properties of the extend to wide categories of food products. Within the product and packaging. In the European Union the other Customs Union and European Union there are three specific requirements related to quality include regulations common areas related to quality that are regulated; along concerning quality associated with a specific territory7 or with this, each market has its own specific areas. The production method8. These regulations are quite specific common areas include nutritional properties of some and there are a limited number of corresponding require- foodstuffs, product composition, and physical properties ments in technical regulations of the Customs Union9. 4 For more details, see European Food Law handbook, Chapter 7. Bernd van der Meulen, Menno van der Velde, Wageningem, 2008. 5 While food safety is an important element of food attributes this topic is covered under a separate review and therefore these attributes are not a part of this document. 6 Manufacturer is responsible for establishing shelf life and storage conditions (CU TR 021/2011) based on multiple normative documents. 7 Those associated with a specific territory in the European Union fall under the area of protected designation of origin or protected geo- graphical indication. 8 This includes quality associated with a production method such as organic/bio or traditional specialty guaranteed. 9 Similar specifications can be found under the TR CU 033/2013 (milk and dairy products) and in draft CU TR 201_/00 (alcoholic products). There is no corresponding technical regulation for organic/bio. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 32 and the Customs Union of Russia, Belarus, and Kazakhstan In the Customs Union quality specifics are usually de- detailing the definitions. The intent of quality character- fined in product definitions where the definitions include istics is to either ensure specific properties of foodstuffs minimum composition requirements in the section of for vulnerable consumers (food for special diets), or to vertical (product-specific) technical regulations that is authenticate foodstuffs for consumers and establish ad- usually called “Safety of.../name of the product group/” ditional labelling requirements, or, in case of fresh fruit (e.g., Article 5, “Safety requirements for fruit and/or veg- and vegetables, establish if they are subject to com- etable juice products” of CU TR 023/2011 “on Fruit and pensation mechanism (though this of course has addi- Vegetable Juice Products”), and in annexes on micro- tional benefits for market development and consumer biology, physical and chemical properties and organo- satisfaction). leptic characteristics. The intent in the Customs Union technical regulations is to ensure that products entered In most cases, the scopes (in terms of the foodstuffs into the market place conform to the specific technical covered) of the corresponding Customs Union and regulations in all attributes. Quality characteristics out- European Union legal acts match only partially, which lined in the Technical Regulations are used to ensure makes the comparison of specific indicators impossible. uniformity of food products offered to consumers, sat- Further, in the case of the Customs Union technical reg- isfy the needs of vulnerable groups of consumers, and ulations, quality-related indicators are usually combined for the purposes of product identification to establish with food safety indicators (in particular, chemical food whether they are subject to conformity assessment un- safety hazards) under a general name “physical-chemi- der the relevant Technical Regulation. cal properties”; in other cases specific indicators relevant to quality characteristics are combined with other indi- Under the European Union, within relevant regulations cators. This combination of indicators can lead to dif- and vertical directives related to quality characteristics ficulties in understanding them, as identification and certain quality characteristics usually can be found as compliance require an in-depth review of each specific definitions establishing minimum composition require- technical regulation, state standards of member states ments of certain single foodstuffs, and in the Annexes (e.g., GOSTs) or regional standard. Requirements to Food Quality in the European Union and the Customs Union 33 Characteristics of requirements to food Customs Union European Union quality  Satisfy the needs of vulnerable  Satisfy the needs of vulnerable groups of groups of consumers; consumers;  Ensure uniformity of food products;  Authenticate a small number of food- Primary purpose of  Enable product identification to es- stuffs for consumers and establish ad- requirements on quality- tablish whether products are subject ditional labeling requirements; related attributes to conformity assessment.  In case of fresh fruit and vegetables, establish if they are subject to compen- sation mechanism.  Nutritional properties;  Nutritional properties;  Composition;  Composition;  Physical properties (organoleptics,  Physical properties (organoleptics, size, List of quality-related size, shape); shape); characteristics covered  Product stability (shelf-life, packaging)  Quality associated with certain produc- tion method or production territory (Organic, PDI, GI, TSI, MP)* Range of products Wide (see below) Narrow (see below) covered Nutritional Foodstuffs for special diets Foodstuffs for special diets Scope of products covered by common properties quality related characteristics Most foodstuffs covered by technical A small number of foodstuffs (coffee regulations (most of milk and dairy, extracts and chicory extracts, honey, sugars, meat and meat products, juices and fruit and vegetable juices and products, fruit Product juice products, oils and fats; in draft jams, jellies, marmalades, dehydrated milk, composition technical regulations – poultry products, cocoa and chocolate, spreadable fats) fish and fishery products, mineral water; potentially – confectionery) Physical properties Certain combinations of physical Water and a small number of agricultural (organoleptic, size properties - all foodstuffs (see above; products (apples, citrus, kiwi fruit, lettuce, and shape) water) peaches and nectarines, pears, strawberries, sweet peppers, green bananas, table grapes and tomatoes) Quality-related Not strictly separated Strictly separated characteristics separated from safety *PDI – Protected Designation of Origin, GI – Geographical Indicators, TSG – Traditional Specialty Guaranteed; MP – Mountain Products Comparative Analysis of Certain Requirements of Food Legislation in the European Union 34 and the Customs Union of Russia, Belarus, and Kazakhstan Comparison of the Specific Quality Characteristics between the Customs Union and European Union A one-to-one comparison of quality characteristics or at- which quality attributes are regulated for broad food cat- tributes between the Customs Union and the European egories and products. The comparison of attributes at a Union is not possible as both Unions have very different high level is conducted below and includes relevant ref- organizational methods for product quality attributes. erences. When in the table below the term “No” is used In general the European Union uses a small number of for the Customs Union, it is not to imply that no standard vertical requirements for specific product groups and or requirement exists but instead is used to communi- single products, whereas the Customs Union uses hori- cate that the Customs Union technical regulations do zontal and vertical technical regulations and numerous not include this area yet, but it is covered by national law regional and national standards (GOSTs and the like) by of member states. Customs Union European Union Attribute Products Technical Regulations and Regulations Directives Specialized for Infants and Children Yes10 Yes11 Nutritional Food for Special Dietary Needs Yes12 Yes13 Properties Substances added for Specific Nutritional Yes14 Yes15 Properties 10 Selected articles and annexes include: CU TR 033/2013 “On Safety of Milk and Dairy Products”; CU TR 034/2013 “On Safety of Meat and Meat Products”, CU TR 023/2011 “Technical Regulations on Fruit and Vegetable Juice Products”, Unified Sanitary Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Control (Supervision), Chapter II Section 9. Requirements for Bottled Drinking Water. 11 Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children. 12 CU TR 027/2012 “On safety of specific types of specialized food products including the therapeutic and preventive dietary food”. 13 Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. 14 TR 033/2013 “On Safety of Milk and Dairy Products”; CU TR 023/2011 “Technical Regulations on Fruit and Vegetable Juice Products”, CU TR 027/2012 “On Safety of Specific Types of Specialized Foodstuffs Including the Therapeutic and Preventive Dietary Food”, Draft CU TR 201_/00 “On Safety of Alcohol Products”. 15 Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses and Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods. Requirements to Food Quality in the European Union and the Customs Union 35 Customs Union European Union Attribute Products Technical Regulations and Regulations Directives Water Yes16 Yes17 Wines and Spirits In Draft Form18 Yes19 Product Coffee and Chicory Extracts No20 Yes21 Composition Fruit and Vegetables Juices Products Yes22 Yes23 Honey Yes24 Yes25 Sugars No26 Yes27 16 Uniform Sanitary and Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Supervision (Control), Approved by Decision of the Customs union Commission № 299 dated 28 May, 2010, Chapter II Section 21. Requirements for Mineral Waters, Chapter II, Section 9. Requirements for Bottled Drinking Water, (as amended by Decision of the Customs Union Commission N 456 of 18.11.2010), GOSTs. 17 Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters and Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. 18 Draft Technical Regulation of the Customs Union “On Safety of Alcoholic Products” (ТР ТС 201_/00). 19 Council Regulation (EC) No 479/2008 of 29 April 2008 on the common organization of the market in wine, amending Regulations (EC) No 1493/1999, (EC) No 1782/2003, (EC) No 1290/2005, (EC) No 3/2008 and repealing Regulations (EEC) No 2392/86 and (EC) No 1493/1999;Commission Regulation (EC) No 1607/2000 laying down detailed rules for implementing Regulation (EC) No 1493/1999 on the common organization of the market in wine, in particular the Title relating to quality wine produced in specified regions, Commission Regulation (EC) No 753/2002 of 29 April 2002 laying down certain rules for applying Council Regulation (EC) No 1493/1999 as regards the description, designation, presentation and protection of certain wine sector products, Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatized wines, aromatized wine-based drinks and aromatized wine-product cocktails of the European Parliament and the Council of 15 January 2008 on the definition, description, presen- tation, labeling and protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89. 20 No specific documents adopted by the Customs Union; National GOSTs and GOST Standards of CIS (adopted by Interstate Council on Standardization) GOST-R 51881-2002 Natural instant coffee. General technical specifications. and GOST R 52088-2003 “Natural roasted coffee” 21 Directive 1999/4/EC of 22 February 1999 relating to coffee extracts and chicory extracts. 22 TR CU 023/2011-Technical Regulations “On Fruit and Vegetable Juice Products”. 23 Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption 24 No specific documents adopted by the Customs Union; National GOSTs and GOST Standards of CIS (adopted by Interstate Council on Standardization) National Technical Regulations of Customs Union member states e.g. Technical Regulation of the Republic of Kazakhstan “Requirements to safety of honey and bee-keeping products” , 05.11.2010. 25 Directive 2001/110/EC of 20 December 2001 relating to honey; Amending 2004/84/EC of 10 June 2004. 26 No specific documents adopted by the Customs Union; National GOSTs and GOST Standards of CIS (adopted by Interstate Council on Standardization) GOSTs included into the list of standards through voluntary compliance, a compliance with Technical Regulation of the Customs Union “On Food Safety” GOST 21-94 Dry sugar. Technical specifications, GOST-R 53396-2009 White sugar Technical specifica- tions, STB 1882-2008 Raw sugar. General technical specifications, GOST 12569-99 Sugar. Rules for receiving and sampling, GOST 12570- 98 Sugar. Methods of testing for moisture content and dry matter, GOST12572-93 Dry sugar and refined sugar. Methods of color testing. GOST 12573-67 Sugar. Methods of testing for ferrous matter. GOST12576-89 Sugar. Methods of testing for appearance sour, taste and clearness of solution. GOST 975-88 Christallised hydrated glucose. Technical specifications. 27 Directive 2001/111/EC of 20 December 2001 relating to certain sugars intended for human consumption.  Comparative Analysis of Certain Requirements of Food Legislation in the European Union 36 and the Customs Union of Russia, Belarus, and Kazakhstan Customs Union European Union Attribute Products Technical Regulations and Regulations Directives Fruit Jams, Jellies and Marmalades No28 Yes29 All meat and meat products, excl. poultry Yes30 No 31 All milk and dairy products, incl.: Yes No Product  Dehydrated Milk Yes32 Yes33 Composition Cocoa and Chocolate No34 Yes35 All fats and oils, incl.: Yes36 No  Spreadable Fats Yes37 Yes38 Gluten in Foodstuffs Yes39 Yes40 28 No specific documents adopted by the Customs Union; National GOSTs and GOST Standards of CIS (adopted by Interstate Council on Standardization); GOST 6442-89 Marmalade. Technical Specifications, GOST 28322-89 Fruit and vegetable products. Terms and defini- tions, GOST R 53118-2008 Jams. General specifications (“Varenie”), GOST R 52817-2007 Jams. General specifications, STB/ОР-2012 Marmalade. General Specifications (State Standard of Belarus). 29 Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for hu- man consumption, Amending Council Directive 2004/84/EC of 10 June 2004 ; Council Regulation (EC) No 1182/2007 of 26 September 2007. 30 CU TR 034/2013 -Technical Regulation of the Customs Union “On Safety of Meat and Meat Products”. 31 TR 033/2013 -Technical Regulation of the Customs Union “On Safety of Milk and Dairy Products”. 32 CU CU TR 033/2013 -Technical Regulation of the Customs Union “On Safety of Milk and Dairy Products”. 33 Directive 2001/114/EC of 20 December 2001 relating to certain partly or wholly dehydrated preserved milk for human consumption; Directive 2007/61/EC of 26 September 2007 amending Directive 2001/114/EC relating to certain partly or wholly dehydrated preserved milk for human consumption. 34 No specific documents adopted by the Customs Union; National GOSTs and GOST Standards of CIS (adopted by Interstate Council on Standardization) GOST 108-76 Cocoa powder. Specifications, GOST R 52821-2007 Chocolate. General specifications, STB 1202-2000 Semi manufactures of chocolate production. Chocolate paste and chocolate glaze. General specifications, STB 1203-2000 Semi manu- factures of chocolate production. Grated cocoa nibs. General specifications, STB1204-2000 Semi-manufactures of chocolate production. Cocoa butter. Specifications, STB 1205-2000 Semi manufactures of chocolate production. Cocoa nibs cake and cocoa nibs powder, gen- eral specifications, STB1206-2000 Semi-manufactures of chocolate production. Milled cocoa-shells. General specifications. 35 Directive 2000/36/EC of the European Parliament and of the Council of 23 June 2000 relating to cocoa and chocolate products intended for human consumption; amended by Regulation (EC) 1137/2008 of the European Parliament and of the Council of 22 October 2008 adapting a number of instruments subject to the procedure laid down in Article 251 of the Treaty to Council Decision 1999/468/EC, with regard to the regulatory procedure with scrutiny. 36 CU TR 024/2011 “On Oil and Fat Products”. 37 CU TR 024/2011 “On Oil and Fat Products”. 38 Council Regulation (EC) No 2991/94 of 5 December 1994 laying down standards for spreadable fats. 39 CU TR 027/2012 on safety of specific types of specialized food products including the therapeutic and preventive dietary food Gluten free (Article 6). 40 Regulation (EC) No 41/2009 of 20 January 2009 concerning the composition and labeling of foodstuffs suitable for people intolerant to gluten. Requirements to Food Quality in the European Union and the Customs Union 37 Organoleptic properties, size and shape are a special This includes Customs Union-recognized standards, case of comparison as the Customs Union by the means as well as national and regional standards (e.g. GOSTs). of reference to standards in its technical regulations sets Standards are category based as well as product based. quality characteristics for most of agricultural products. Customs Union European Union Attribute Products Technical Regulations and Regulations Directives Milk and dairy Meat and meat products Fruit and vegetable juice products Bottled drinking water Organoleptics Yes41 No Oils and fats (colour, taste, odour, Alcoholic Beverages appearance), and Food for infants and children (milk, meat size and shape and juice based) where relevant Agricultural products Yes – limited set of products focused No42 on 10 fresh fruit and vegetables commodities43 A general rule applies to compliance with the Customs member states apply. The GOST standards referenced Union technical Regulations: a manufacturer may to in the table above for the Customs Union are only choose whether to comply with the technical regulation a sampling of the long list of product-specific techni- itself, or with a set of regional standards (GOSTs), a list of cal standards. There are many additional standards and which supports each technical regulation. Compliance technical documents, therefore prior to exporting com- with these standards is voluntary but meets the require- panies must ensure they comply with the specific tech- ments for compliance with the technical regulation. nical requirements of not only the Customs Union but Further, in case where norms are absent in the Customs also of its member states. These standards are available Union technical regulations, national norms of the on-line and in some cases in English44. 41 CU TR 033/2013 “On Safety of Milk and Milk Products”; CU TR 034/2013 “On Safety of Meat and Meat Products”; CU TR 023/2011 “Fruit and Vegetable Juice Products”; CU TR 024/2011 “On Fat and Oil Products”; Draft CU TR 201_/00 “On Safety of Alcoholic Products”; Uniform Sanitary and Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Supervision (Control), Chapter II, Section 9. Requirements for Bottled Drinking Water . 42 See, for example, GOSTs included into the list of standards through voluntary compliance, a compliance with Technical Regulation of the Customs Union “On Food Safety”: GOST16270-70 “Fresh apples of early ripening. Specifications”, GOST 21122-75 “Fresh apples of late ripening. Specifications”, STB 2083-2010 “Vegetables green fresh. Requirements at preparations, deliveries and realization”, GOST 21713-76 “Fresh peas of late ripening. Specifications”; national rules apply in the case when Customs Union requirements are absent. 43 Products include Apples, Citrus (including clementines, satsumas, oranges, lemons and mandarins), Kiwi Fruit, Lettuce (including curled and broad leaved endives), Peaches and Nectarines, Pears, Strawberries, Sweet Peppers, Table Grapes and Tomatoes). PLUS green bananas at the point of import. 44 http://www.runorm.com/gost-gost-r-standards as well as other sources including the European Union and USDA but these are unofficial translations and documents in the original language should be consulted prior to exporting. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 38 and the Customs Union of Russia, Belarus, and Kazakhstan “Increasingly a number of consumers attach greater im- Customs Union, with the exception of alcoholic bever- portance to the food with specific characteristics in their ages (the technical regulation is still in the draft form), diet rather than to quantity”. This statement was one of there is no analogue at present. At the same time, speci- the European Union’s main justifications for introducing fications that are developed for each product with PDO the four European Union quality schemes related to: and PGI, to a significant extent have a similar structure 1. geographical indications of origin (PDO); and contents as GOST standards. Since PDO, PGI, TSG 2. protected designations guaranteed (PDI); and MPs are a unique interpretation of food quality, a more detailed description of these quality schemes has 3. traditional specialties (TSG), and been included. 4. mountain products (MPs), (voluntary quality term). These systems became a part of the European Union Protected Designation of Origin (PDO) covers the term agricultural product quality policy.45 This quest for food used to describe foodstuffs which are produced, pro- with specific properties generates a demand for agri- cessed and prepared in a given geographical area us- cultural products or foodstuffs with an identifiable geo- ing recognized know-how (Prosciutto di Parma (Parma graphical origin or traditional receipts. In view of the ham), Žatecký chmel (Zhatetsky hop)). Protected wide variety of products marketed and the abundance Geographic Indicators (PGI) indicate a link with the area of product information provided, the consumer should, in at least one of the stages of production, processing or in order to be able to make the best choice, be given preparation (such as Holsteiner Tilsiter cheese, “Slovenski clear and succinct information regarding the product med”, “Gornooryahovski sudzhuk”). The link with the origin. To meet these consumer needs the European area is therefore stronger for PDOs. Traditional Specialty Union developed a set of quality characteristic schemes Guaranteed (TSG) means a traditional agricultural prod- that focus on product properties associated with certain uct or foodstuff recognized by the Community for its production area or traditional production method. The specific character. The optional quality term “mountain intent of these regulations is twofold. product” is designed for food products originating from 1. The first is to protect product names from mis- mountain areas. The use of corresponding EU symbols use and imitation and protect consumers in that on the labels of such products provides consumers with products that carry certain designations in fact clear and concise information on the product origin meet the requirements. and/or character. 2. The second is to provide producers at all levels the opportunity to capture additional value by Each of these food quality systems have specific re- creating European Union marks which are used quirement for registration, certification and labeling. This for advertising and promotion of products. is a highly transparent system that has created over 700 registrations by 2011.46 Protected Geographical Indications (PGI) and Protected Designation of Origin (PDO), as well as Traditional Organic/Bio certification is an additional food and ag- Specialty Guaranteed (TSG) and Mountain Products (MPs) riculture quality scheme within the European Union. establish special rules under which products can be rec- Organic production47 in the European Union has reached ognized as belonging to one of the European quality dramatic proportions with consumer spending on or- schemes; for each food product under the schemes, a ganic food products of ~ $40 billion US in 2012. There separate specifications document is developed. In the are more than 186,000 organic farms across Europe, 45 Bio-based and Applied Economics 1(2): 213-229, 2012, Consumers’ Awareness and Attitudinal Determinants of European Union Quality Label Use on Traditional Foods, Wim Verbeke1, Zuzanna Pieniak, Luis Guerrero, Margrethe Hersleth. 46 All registrations for PDO, PGI and TSG are kept by a European database called DOOR http://ec.europa.eu/agriculture/quality/door/list.html). Also, rules and PGI, PDO and TSG specifications in English language and for British foodstuffs and agricultural products can be found at the relevant UK website https://www.gov.uk/protected-food-names-guidance-for-producers. Other EU member states maintain similar websites in their national languages. 47 Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labeling of organic products and repealing Regulation (EEC) No 2092/91. Requirements to Food Quality in the European Union and the Customs Union 39 cultivating an area of 9.6 million hectares representing but includes animals and animal products. By 2011 there about 5.4% of the total agricultural area in the European were over 2.6 million head of certified organic cattle in Union48. Further, organic is not limited to crops and food the European Union49. Important Notes for Governments, Policy Makers and Industry Governments, Policy Makers regulations. Therefore harmonization with the Customs Union technical regulations can be more difficult. The European Union and the Customs Union vary sig- nificantly in their approaches to “food quality”. The fun- The European Union has several specific qual- damental difference is that within the Customs Union, ity schemes: Geographical Indications (PGI), Protected all foodstuffs and agricultural products have product- Designation of Origin (PDO), Traditional Specialty specific regulated quality parameters that are defined Guaranteed (TSG), optional term “Mountain product” in Customs Union Technical Regulations, regional stan- and Organic for agricultural and food products. These dards or national standards (GOSTs). Alternatively, in the schemes are designed to meet the consumers need for European Union, quality parameters are determined by information on the products they consume as well as the market place and are designed by the producer and/ the ever increasing demand for specialty products and or manufacturer to meet consumers stated and unmet organic products. These schemes provide a mechanism needs. In only a few specific cases in the European through labelling and branding to increase the value of Union are food quality characteristics regulated. products and thus have the potential to increase farm incomes. Further there is not a one-to-one relationship between the Customs Union and European Union legal acts Basically, the two models of approaching food quality (where they exist in the EU) that cover food quality char- create the following significant implications: acteristics. In cases where the corresponding legal acts  European Union: increased product variabil- exist in the European Union and the Customs Union, ity, lower market protectiveness, and higher their scopes do not match in terms of specific products competition: covered; regulated parameters differ on a case-by-case  Customs Union: product uniformity, higher mar- basis. Because of the significant differences in approach ket protectiveness, and the need to maintain a between the Customs Union and the European Union high level of standardization. harmonization of laws and regulations simultaneously to both Unions by any government or policy makers is Governments and policy makers have a significant role impractical and impossible. in helping industry understand and comply with the quality requirements of the target export markets. To this The need for having specific technical regulations for end governments can develop and carry out trainings each product creates a significant complexity within through universities, trade associations and other orga- the legal acts. It has been noted that under the Custom nizations on the specific quality characteristics of prod- Union regulations there is significant inconsistency ucts required to meet the Customs Union and European as to format and materials included in the technical Union regulations. 48 Frequently asked questions: Commission proposals for new rules for organic farming, European Commission, Memo, Brussels, 25 March 2014. 49 Facts and figures on organic agriculture in the European Union, October 2013. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 40 and the Customs Union of Russia, Belarus, and Kazakhstan Industry investments may be needed to study consumer prefer- ences and adjusting/developing the product accordingly; Food quality characteristics are regulated in the European Union and Customs Union for different pur- Customs Union: quality is meeting a set of prescribed poses: in the European Union they are used to authenti- technical requirements; the requirements need to be cate the product for consumer and are closely related to studied thoroughly and complied with; any alteration to labelling; in the Customs Union they are mainly used for the product shall stay within the established quality pa- identification purposes to determine whether a product rameters, otherwise the market access can be restricted. is subject to assessment of conformity against Technical Regulations. These differences are significant enough Industry is responsible for compliance to either Union’s that industry cannot assume that products that meet requirements. Companies that wish to export to the one Unions’ regulation does not confer compliance Customs Union and/or the European Union must with the other. avail themselves of the specific requirements. This can be a complex task in that the details of the technical The industry needs to clearly understand what will be regulations of the Customs Union and the laws of the required from them in terms of product quality at each European Union are quite different and therefore un- of the two markets: derstanding each one takes time and resources. Further industry must take into account the National and GOST European Union: quality is meeting consumer needs standards when exporting to the Customs Union and as they are at the time of purchase; therefore certain member states. Requirements to Food Quality in the European Union and the Customs Union 41 Comparative Analysis of Certain Requirements of Food Legislation in the European Union 42 and the Customs Union of Russia, Belarus, and Kazakhstan Requirements to Food Labeling in the European Union and the Customs Union when labels are required, where on the packaging the labels are placed, and the format and specific content of the labels. These requirements are designed to ensure that consumers receive important and fair information about the foods they consume. The responsibility for compliance is shared between the manufacturer and government Executive Summary agencies. Manufactures and to some extent importers The globalization of the food industry combined with must ensure that the products that are sold to a specific ever changing consumer preferences and demands country or a union comply with the specific labeling re- has led to explosion in the number and types of food quirements defined in the laws and technical regulations products available to consumers. Traditional food retail of the target market. The government is responsible to stores carry between 10,000 and 60,000 different food ensure through enforcement that the laws and technical items and each year thousands of new food items are regulations are adhered to. introduced. Consumers choose products based on a complex set of criteria such as brand, cost, healthiness, Food labeling laws of different marketplaces have freshness, taste, visual appearance, culture, and lifestyle. evolved based on the single concept of fair information These drivers compel retailers and manufacturers to de- to consumers, as well as on specific market-related in- velop communication tools to differentiate their products formation depending on local practices and consumer in the market place in order to retain clients and maximize expectations. Through international trade, many of the profits. A critical component in attracting consumers is food labeling requirements have been brought to simi- the labeling. Labeling provides a range of information larity or equivalence; however significant differences re- to consumers such as the product name, manufacturer, main and there is no single food labeling requirement price, contents of the product, and directions for use and and format that have been adopted globally. storage. Some of the product details the labels provide are essential (use-by dates, safety warnings, etc.), other infor- The complexity of labeling has always been a challenge for mation is considered useful (nutrition labeling, recycling the food industry. Compliance with labeling rules requires details, etc.). that food industry develops expertise and experts in label- ing who can provide the knowledge needed to ensure that Governments and policy makers also recognize that la- the products are properly and completely labeled in ac- bels can convey information that is critical to the health cordance with the requirements of the country in which and well-being of vulnerable consumers, and require the products are to be sold. Failure to comply can lead to provision of additional details that allow consumers to products being delayed upon importation and/or rejected, make informed choices. This has led to the incorpora- both of which cause significant business disruption and fi- tion of rules on health claims as well as other relevant nancial losses to the buyer and seller of the products. information to the labeling requirements. Such informa- tion ranges from identification of allergens that are fatal The Customs Union and the European Union have ex- to some consumers to declaration of salt, fat, caloric and tensive labeling requirements for food products which vitamin content; to information on country of origin, are designed to inform and protect consumers. For food whether the product is organic, and designations indi- business operators, including producers, manufacturers, cating how or where a product is produced. All of these importers, and food catering compliance with labeling particulars are designed to help ensure the health and requirements can be a difficult and complex task. The well-being of consumers and allow consumers to make Customs Union and the European Union each have spe- informed choices based on their specific preferences. cific requirements that while in general cover the same basic areas, differ by the specifics of what information Food labeling laws establish the framework which manu- must be contained on the label and how the information factures are required to comply with. These laws establish is presented. 1 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 44 and the Customs Union of Russia, Belarus, and Kazakhstan Further, labeling requirements continue to evolve. In the have become the best labeling practice internationally; European Union a new Regulation (EU) 1169/20111 on technical regulation CU TR 022/20112 on food products Food Information to Consumers entered into force on labeling became compulsory after February 15, 2015 December 13, 2014 and introduced new requirements when the transition period ended. Also, the Customs and amended the existing ones. The Customs Union Union continues to develop vertical technical regula- is in the process of developing its requirements based tions for specific product groups that contain additional on those that exist in the member states and those that labeling requirements as well. General Comparison between the Customs Union and European Union Legal Frameworks on Food Labeling The general purpose and intent of food labeling in the requirements to selected food items, the Customs Union Customs Union and the European Union is similar. requirements on additional labeling details cover broad Labeling should provide consumers with information food categories. Moreover, the Customs Union is adding necessary to make informed decisions, prevent mislead- significantly to the body of requirements and over time ing of consumers, and create a degree of uniformity in it is anticipated that specific technical regulations for all the labels to facilitate trade within the respective Unions. food products and beverages will be developed and put While both Unions have some degree of commonal- into force. ity in purpose and intent, the European Union further establishes that labels and labeling requirements have a The horizontal regulations of the Customs Union and broader contribution to society including simplification European Union have similar basic labeling require- of the laws of the Union, ensuring legal certainty, reduc- ments – from product name, list of ingredients and ing administrative burden, and improving competition. quantity contained, to use instructions and nutritional value. Also both Unions have additional labeling require- Ensuring competition is unique to the European Union, ments for certain products including: infant and baby and it is recognized that labeling plays a key role in con- products, special diet food, organic/bio or environmen- sumer choice and therefore competition within the tally pure products, food products that may contain ge- market place. Further the European Union recognizes netically modified organisms, and food that may have that consumer preferences and demands for informa- special health effects. tion will change over time. Therefore, the European Union has established that one of the fundamental pur- There are differences between the scope or span of poses of the labeling regulations is to provide sufficient the regulations between the Customs Union and the flexibility to be adaptable to consumers changing needs European Union. Both Unions have their own specific for information. labeling requirements for products sold directly to con- sumers, pre-packed food, and food during transpor- Food labeling is part of food information and is regulated tation. While EU Regulation (EU) 1169/2011 applies to as such. The Customs Union and the European Union all food sold to final consumer, including that served legislation on labeling of foodstuffs is a combination of through catering (except for occasional events like fairs), horizontal and vertical legal acts. The basic horizontal in the Customs Union food products produced by ca- documents set general requirements to food labeling tering establishments are excluded from labeling re- concerning all types of food, and a number of vertical quirements. In the case of catering and restaurants the documents regulate additional labeling requirements European Union further states that consumers must be for selected specific food products or product groups. informed of specific ingredients such as allergens either In the European Union, the number of such specific through information on the menu or orally communi- products that require additional information on the label cated to ensure consumers are informed of potential may seem to be broader than in the Customs Union to- hazards. day, but while the European Union sets such additional 2 Technical Regulations of the Customs Union CU TR 022/2011 “On food products in terms of their labeling”. Requirements to Food Labeling in the European Union and the Customs Union 45 Comparison of Specific Labeling Requirements of the Customs Union and the European Union While there are significant similarities between the la- may seem to be a nuance, it has a significant impact beling requirements of the Customs Union and the on business operators that wish to supply catering and European Union this is not meant to imply that compli- food service in the European Union as the specific food ance with one or the other confers compliance across labeling requirements apply. This is especially relevant as both Unions. In fact it is quite the opposite as the specif- the food sales from the food service industry (hospital- ics of the laws and regulations are quite different and ity, catering and restaurants) have reached stunning pro- while the differences may seem slight to the casual portions in the European Union with sales in excess of reader they are in fact significant enough to prevent ar- $184 billion annually between the French and German ticles from being placed into circulation in either Union markets alone3. Therefore compliance to labeling is re- as compliance to all of the specific details is required. quired for companies to participate in and supply to this significant target export market. The difference between the two Unions begins with the fundamental definition of labeling and scope of label- It was mentioned already that at the first glance the ing. While both Unions define labeling as any words, requirements for what must be included on the label particulars, trademarks, brand name, pictorial matter or (mandatory particulars) are the same in the Customs symbol relating to a food, they differ as to when the la- Union and European Union as the basic intent is to pro- beling must be used. In the Customs Union labeling vide consumers with specific information. Both Unions requirements are focused on consumer packaging and require information on content, quantity, naming con- transport packaging, and an information carrier must ventions, use and preparation, identification of certain be attached, affixed or enclosed to the product packag- potential health hazards such as allergens, nutritional ing. In the European Union labeling is required in some value and contact information on each product. Yet the format on any type of packaging as long as the food information required and how it is presented varies and inside is intended for final consumer or caterer, and an in many cases varies significantly. Table 1 contains high- information carrier can also refer to food, not only be lights or summaries of the differences between the two attached, affixed or enclosed (e.g., a menu in restaurant Unions as well as the implications for manufactures and is a carrier of food information to consumers). While this exports. Labeling Mandatory Particulars – A Comparison between the Customs Union and the Table 1 European Union Requirement Customs Union4 European Union5 Implications Food labeling shall be written Mandatory food information Labels may contain multiple in the Russian and in the state shall appear in a language(s) languages and it is important language of the Customs Union easily understood by the con- Language for business operators to Member State; when sold to sumers of the Member States identify what languages are Russia, only in Russian where a food is marketed required therefore 3 USDA Gain Report FR9086 and USDA Gain Report GM13002. 4 Technical Regulation CU TR 022/2011 “On food products in terms of their labeling” . 5 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 46 and the Customs Union of Russia, Belarus, and Kazakhstan Requirement Customs Union4 European Union5 Implications Requires labeling for con- Requires labeling for consum- sumer packaging and transport er packaging and multi-packs Depending on the intended packaging as long as they are intended market labeling require- Packaged Food for final consumer; labeling ments vary between the two of non-pre packed food is Unions regulated by national laws of member states Labeling shall be clear, readable, There are specific require- Exporters and business adequate and not misguiding for ments as to the appearance, operators must consult the Appearance, consumers; the inscriptions, signs, location and size of the man- specific requirements for ap- Locations and symbols shall be contrasting to datory product information pearance, location and size Size of Text the background to which the on the label. of text if they wish to export labeling is added6 to the European Union. Only general requirements with The name shall be under- regard to the name of food are stood by consumers in the established and detailed require- country of sale, not in the ments are contained in the prod- country of production. uct-specific technical regulations7 Food can be given one of the General requirements on product three types of names: legal name: name (name designated to  Shall allow for classification, the product by law), or cus- characterizing, and distin- tomary name, or descriptive guishing the product from name. other food products. In addition, name must  Shall include physical prop- include or be accompanied erties and (or) special food by a designation of the product treatment treatment applied, if any (e.g,.  If the food product includes a dried, frozen). Naming conventions be- flavoring this may be indicated tween the two unions vary In specific cases the name Name of greatly and must be taken  The name shall not be same need to include: Product into consideration prior or similar or remind names  physical condition of the to export to either of the of products for which GOST product (e.g., powdered, Unions. standards exist, uncles the refrozen); product complies with those  “defrosted” where  A number of names are re- applicable; served for “classic” products of  “irradiated” where pre-determined composition; applicable; other products cannot be giv-  source of added proteins en such names (e.g., cheese in meat products where cannot be named “cheese” if it applicable; contains vegetable oil – it is a  presence of water >5% in “cheese product” then) meat products;  formed meat and formed fish;  designation of minced meat (e.g. % fat content). 6 Within the Customs Union only fats and oils and dairy products have specifications as to font size. 7 Specific Customs Union naming conventions for meat and meat products, milk and dairy, fruit and vegetable juices, fats and oils and food for special dietary purposes can be found in the product specific technical regulations Requirements to Food Labeling in the European Union and the Customs Union 47 Requirement Customs Union4 European Union5 Implications There are numerous specific There are numerous spe- To a significant extent requirements for ingredients cific requirements for listing requirements on the list ingredients. of ingredients are simi- Different from the Customs lar, equivalent or partially Union are the requirements equivalent between the on: European Union and the  Compound ingredients; Customs Union.  Ingredient as a foodstuff Partially equivalent is meant List of  Reconstituted ingredients to convey that additional re- Ingredients quirements are set by either  Similar or mutually sub- the European Union or the stitutable ingredients that Customs Union. do not change state of the product and present in the Exporters and business amount <2% operators must consult the  Nano materials specific regulations to ensure that product labels meet the requirements. There are 15 substances for which There are 14 substances specific labeling is required; 14 of (causing allergies or intoler- The list of substances caus- them are the same as in the EU ances) for which specific ing allergies or intolerances (substances causing food allergies labeling is required; these are Substances for which labeling is required or intolerances); the 15th sub- the same as in the Customs Causing is nearly identical between stance is aspartame and aspar- Union. Aspartame is regulat- Allergies or the Unions. But there are tame-acesulfame salt; additionally ed under a separate regula- Intolerances specific differences as to the there is specific requirements for tion. Indications “gluten-free” wording and how the infor- “gluten-free” declaration and “very low gluten” is mation is communicated. regulated under a separate regulation Quantity No requirements This is unique to the Exporters and business of Certain European Union, and does operators wishing to export Ingredients or not have an equivalent in the to the European Union must Categories of Customs Union. comply. Ingredients Units of measure to be used de- Units of measure that can be Specific requirements to pending on whether the product used depending on whether quantity declaration with re- is solid or liquid the product is solid or liquid gard to multi-pack packages Requirements to quantity decla- Requirements to quantity are different: ration with regard to multi-pack declaration with regard to Customs Union indicates a packages multi-pack packages total (combined) quantity of Net Quantity of Quantity declaration for foodstuffs Quantity declaration for food- packages in the multi-pack the Food placed in liquid media stuffs placed in liquid media package, and number of packages inside. European Union indicates an individual quantity of each package in the multi-pack package as well as number of packages inside. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 48 and the Customs Union of Russia, Belarus, and Kazakhstan Requirement Customs Union4 European Union5 Implications This is unique to the Customs No requirements Manufacture date means Union and does not have an the date of the end of the equivalent in the European Union process of production of Manufacture particular types of food Date products. This must be incorporated into the labels for products exported to the Customs Union. The terms “use by” or “best be- “Best before...” is used to indi- The distinction between fore” are used interchangeably but cate a date of minimum du- “best before” and “use by” is there are specific formats detailed rability of a food, or, in other only made in the European as to how the information is words, the date by which Union and they are not inter- provided. the food retains its specific changeable and therefore it “Use by” or consumer properties when is important that the proper “best before properly stored. term be used for export to date” For foods which, from a this market. Formatting of microbiological point of view, the information is different are highly perishable, the term between the Unions and “use by” shall be used. Beyond therefore exporters and busi- the date the product is con- ness operators must comply sidered potentially unsafe. with differing specifications. Any Special These are required and set by the Storage conditions are estab- Storage specific technical documents lished by manufacturer Conditions and/ Exporters to the Customs or Conditions Union must familiarize of Use themselves with the specific Example: Once technical documentation for opened keep each product or product cat- refrigerated and egory to ensure compliance consume within 3 days The name of food manufacturer Any business operator under shall be indicated. The name shall whose name the food is mar- be a legal name, not the name of keted, who may not be the For exporters and business Name or doing business manufacturer operators each Union has Business Name It is mandatory to indicate both Only importer name in case different requirements as to and Address the manufacturer name and the of import the information required of the Food importer name It is sufficient to indicate only on the label with regards to Business It is important whether location of one address, as chosen by the manufacturer, facility and Operator or the manufacturer is the same as operator which organization(s) must Importer location of the facility, and if they be indicated are different, both addresses must be indicated Not required. Partially covered Is unique to the European This is specific to the Country of by the indication of manufacture Union and was designed European Union. Exporters Origin or Place address to inform consumers from and manufactures must of Provenance where their foodstuffs came comply with specific details Labeling from and covers a range of on COOL with regard to (COOL) products8 specific products as indi- cated in the regulations. 8 Honey, milk, meat, fruit and vegetables and processed fruit and vegetables, nuts, olive oil and fishery and aquaculture products. Requirements to Food Labeling in the European Union and the Customs Union 49 Requirement Customs Union4 European Union5 Implications Instructions for It is required to put recommenda- The textual instructions for Use tions and (or) restrictions on use, use of a food shall be indicat- For example: on cooking of food products in ed in such a way as to enable In the European Union Quick frozen cases where without such recom- appropriate use of the food. textual descriptions are peeled cooked mendations or restrictions using required but these can be shrimps: Do not the food item is difficult, or may supplemented by the use of thaw. Put in the harm the consumers’ health or pictograms. boiling water property, lead to reduction or loss and cook for 3 of palatability characteristics of minutes food products. Currently not required, however All pre-packed drinks with an Manufactures and exporters a draft Technical Regulation “On alcoholic strength of more to the Customs Union need Safety of Alcoholic Products” has than 1.2 % (abv) must be to be aware that a new tech- Beverages been developed. Until it is ad- labeled with an indication of nical regulation on alcoholic with more opted and in force, falls under the alcoholic strength by volume products has been drafted than 1.2 % by national regulations and will be implemented in Volume of the future. Till then, they shall Alcohol comply with national laws of the Customs Union member states. Nutrition value does not have to Nutritional declaration be specified does not apply to food supple- for flavorings, chewing gums, cof- ments, natural mineral water, fee, natural mineral water, bottled but it applies without prejudice drinking water, food additives, raw to the requirements set for food products (mushrooms, prod- food for special diets. ucts of farm animals and poultry Nutritional declaration applies slaughter, fish, vegetables (includ- to all other food stuffs not In the EU nutrition declara- ing potatoes), fruits (including specifically excluded. tion becomes mandatory in berries), sodium chloride, herbs, December 2016. The mandatory nutrition spices, vinegar, tea. Nutritional labeling require- declaration shall include the May be omitted for certain other following: ments differ greatly between types of foodstuffs if Customs the Customs Union and  energy value; and Union technical Regulations for European Union nutritional Nutritional  the amounts of fat, satu- particular types of food products information, what informa- Declaration rates, carbohydrate, sugars, allow for this. tion is required, how the protein and salt. Mandatory for all other foodstuffs. information is determined In addition, may include an and how it is presented. The nutrition value of food indication of the amounts of products specified in the labeling Therefore prior to export the one or more of the following: thereof shall include the following manufacturer and exporter  mono-unsaturates; indicators: must consult the relevant  polyunsaturates; requirements.  Energy value (caloric content);  polyols;  Protein, fat, hydrocarbon  starch; quantity;  fiber;  Vitamins and mineral sub-  any of the vitamins or stances quantity. minerals that are specially listed and present in sig- nificant amounts Comparative Analysis of Certain Requirements of Food Legislation in the European Union 50 and the Customs Union of Russia, Belarus, and Kazakhstan Requirement Customs Union4 European Union5 Implications This requirement is mandatory According to a separate legal for food in transport packaging document, all pre-packed It is important that manufac- and establishes that on a transport foodstuffs (in consumer pack- turers and exporters to the packaging information shall be ages) must bear on the label a European Union understand placed that allows for identifica- manufacturing or packaging what is specifically required Lot tions of a lot of food product lot reference9, a system which in terms of information and Identification is harmonized throughout the format with regard to lot European Union. The lot ref- identification as well as the erence allows consumers to definition of a “lot” as it im- trace the product in the event pacts labeling compliance of any dispute or health risk. This requirement only applies to No equivalent requirements the products put into circulation for food products exist For the potential exporters to in the Customs Union. The single the CU market, it is important mark of circulation is placed only to remember that the single on products that passed all con- mark is a visual evidence of formity assessment procedures Single Mark of completing conformity as- (according to technical regula- Circulation at sessment procedures. It can tions). Foodstuffs that comply only the Market not be obtained otherwise, with the CU TR on Food Labeling and is illegal to be used on (but have not passed conformity the label without complet- assessment procedures accord- ing conformity assessment ing to other applicable technical procedures. regulations) cannot bear the single mark of circulation at the market Beyond the general labeling requirements prescribed by required for specific products or product categories. In the Customs Union and the European Union for spe- some cases these requirements are elaborated in both cific categories of products and/or for communication Unions, in other cases they are Union-specific. of specific information additional labeling particulars are Table 2 Summary Products, Categories or Information for which Specific Labeling is Required (Note: “No” means that no additional requirements on labeling are established beyond the general requirements applicable to all foodstuffs or their broad categories) European Product or Category Customs Union Union Natural Mineral Waters Yes Yes Foodstuffs for Particular Nutritional Uses Yes Yes Infant Formula Yes Yes 9 Directive 2011/91/EU of the European Parliament and of the Council of 13 December 2011 on indications or marks identifying the lot to which a foodstuff belongs. Requirements to Food Labeling in the European Union and the Customs Union 51 European Product or Category Customs Union Union Processed Cereal-Based Foods and Baby Foods for Yes Yes Infants and Young Children Foods Used in Energy-Restricted Diets for Weight Yes Yes Reduction Dietary Foods for Special Medical Purposes No Yes Foodstuffs Treated with Ionizing Radiation Yes Yes Quick-Frozen Food No Yes Production and Labeling of Organic Products Yes Yes Traditional Specialties Guaranteed For Milk partially Yes No; the draft technical regulations “On Safety of Alcoholic Products” includes only Geographical Indications and Designations of Origin Yes definitions that are similar to the European Union Food and Feed (GMO) Yes Yes Novel Foods and Food Ingredients No Yes Health Claims Yes Yes Food Supplements No Yes No, but draft technical regulations “On Safety Labeling of Wine and Certain Other Wine Sector of Alcoholic Products” includes definitions that Yes Products are similar to the European Union Coffee and Chicory Extracts No Yes Caffeine and Quinine Yes Yes Identification and Labeling of Beef and Veal Yes Yes Oils and Fats/Spreadable fats Yes Yes Preserved Milk Yes Yes Edible Caseins and Caseinates Yes, but limited Yes Fruit Juices and Similar Products Yes Yes Fruit Jams and Sweetened Chestnut Purée No Yes Aromatized Drinks No Yes No, but draft technical regulations “On Safety of Alcoholic Products” includes definitions Spirit Drinks/Alcoholic Beverages Yes many of which are similar to the European Union Sugars No Yes Cocoa and Chocolate No Yes Honey No Yes Fishery and Aquaculture Products No Yes Comparative Analysis of Certain Requirements of Food Legislation in the European Union 52 and the Customs Union of Russia, Belarus, and Kazakhstan When at the Customs Union level specific requirements  HACCP is compulsory and does not give a com- to labeling of certain foodstuffs listed above do not exist, pany any distinctive feature compared to other they may exist in the Customs Union member states, companies; and are based on national laws and/or GOST or other  HACCP certification is not required by the state standards. Therefore for products like sugars, co- European Union regulations; compliance with coa, honey etc. the national provisions and GOST/state HACCP is checked through audits by official con- trol authorities and the result is a facility approval; standards must be consulted prior to exporting to spe- cific countries within the Customs Union.  HACCP refers to general conditions under which product has been produced or handled, not to any specific characteristics the product has. Finally, the use of logos or marks associated with specific food safety management systems (FSMS) that are based At the same time, the EU law does not restrict food busi- on voluntary private standards and include HACCP10 re- ness operators from using marks of the private stan- quirements are allowed within the Customs Union and dards; however, as the use of such marks is a part of the European Union, but the use of these is regulated commitments assumed by FBOs at voluntary certifica- differently. The basic difference is that in the European tion, FBOs shall follow rules on use of the logos/marks Union the use of such marks is applicable on all carri- established by the owners of the standards. For exam- ers accompanying the product except for its packaging, ple, International Standardization Organization estab- while in the Customs Union it is allowed on the packag- lished that ISO certification marks shall not be used on ing as well. a product or product packaging seen by the consumer or in any other way that may be interpreted as denot- In the European Union, rules for use of voluntary stan- ing product conformity12. ISO certification marks can be dards (as well as their certification marks) are dictated placed only on other carriers, like company brochures, by the owners of the standards and are not set by the advertisements, and so on. European Union; because such standards and logos are voluntary, EU legal acts do not address this issue at all, The Customs Union established13 that packaged food leaving it to the owners of the standards. Private stan- product labeling may include additional information, dards on HACCP-based FSMSs shall be clearly distin- including, inter alia, marks of various voluntary certifi- guished from legally compulsory HACCP requirements: cation systems. It shall be interpreted as allowing to put they have very different scopes, and while the private marks of certification against GOST standards, because standards are certifiable, no certification of mandatory GOST standards are product standards (versus system HACCP is made. In this regard, a special remark should standards) and the rules of GOST certification system be made about the use of marks containing the word support this. But it shall not over-rule procedures and HACCP. As HACCP is compulsory in the European policies of owners of voluntary FSMS standards, even Union by EU Regulation 852/200411 for all food business when certifications are offered by the same certification operators dealing with all foodstuffs other than primary bodies as those offering GOST certification. In practice, products, no inscriptions or marks like “HACCP certified”, it means that general rules established by the owners “manufactured according to HACCP” or the like can ap- of the FSMS standards shall apply; in particular, placing pear on the labels of food sold in the European Union. certification marks of these standards on product labels There are three reasons for this: is not acceptable. 10 HACCP – Hazard Analysis and Critical Control Points. 11 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, Article 5. 12 ISO/IEC 17021:2011 ““Conformity assessment. Requirements for bodies providing audit and certification of management systems”, Section 8.4.1 (Reference to certification and use of marks”). 13 CU TR 022/2011 “Food products in terms of their labeling”, Clause 4.1.3. Requirements to Food Labeling in the European Union and the Customs Union 53 Important Notes for Governments, Policy Makers and Industry Governments and Policy Makers requirement is designed to ensure that, i.e., those con- sumers who are affected by food allergens will receive The labeling requirements of the European Union and information that can protect their health and well-being. the Customs Union are detailed and well elaborated. While in general the labeling requirements are quite Finally while not specifically reviewed in this document, similar, as they are designed to provide basic informa- a part of intent of the European Union labeling law is tion relevant to health and well-being of consumers, to facilitate the accessibility of food information to the the specific requirements differ. Therefore simultane- visually impaired. With the aging of the population in the ous harmonization to both Unions is impractical and European Union access to information for those with impossible. visual impairment represents an opportunity to improve well-being of its citizens. This intent while not fully real- The differences in labeling requirements between the ized may provide a starting point for labeling require- Customs Union and the European Union can be found ments that meet the needs of an important socially on three levels: the highest level of scope, purpose and vulnerable segment of the population. intent, the level of general requirements, and the level of specific requirements to particular foodstuffs. Therefore Due to the complexity of labeling requirements in the in order to model one or the other of the Unions’ laws European Union and Customs Union it is recommend- and technical regulations policy makers will need to take ed that the governments, trade associations, and educa- into consideration the specific requirements at all policy tional institutions develop specific labeling manuals and levels as well as the implications for industry. training courses for the industry to help ensure com- pliance of products to the target market destinations. In the Customs Union while horizontal requirements These courses should range from introductory over- to labeling exist, specific additional requirements are view courses to product or commodity specific training set separately for large groups of foodstuffs in vertical and educational materials. Technical Regulations and in some cases through na- tional laws established by the individual member states. In contrast the European Union relies on a set of hori- zontal regulations to define labeling requirements that Industry are generally the same for all except for a limited set of While the differences in food labeling rules between the food products. two markets do exist, they do not prevent compliance. Industry has the capability to meet the general and spe- Furthermore, since labeling requirements are not static cific requirements of each of the Unions. It will require in either EU or CU and are undergoing further elabora- that labels for each Union be prepared separately, and tion, governments wishing to harmonize with one or this is not only a matter of the language, as no one la- the other of the Unions must be prepared to change bel will meet all of the requirements of either market by their laws and have the legal basis that is flexible enough default. to allow for further changes of laws and/or technical regulations over time. Importantly, in the Customs Union labeling is one of the requirements that comprise a set of specifications There are some special designations in the European for mandatory conformity assessment (in the form of Union that are not a part of the Customs Union law, declaration of conformity); non-compliance may result including special designations for products by name, in no access to the Customs Union market. At the same designations for specific geographical locations, and time, industry must remember that where there are no traditional preparation. requirements of the Customs Union, national rules of member states apply, and be aware of those as well. In addition, the European Union requires that informa- tion on food products are communicated to consumers According to the EU Rapid Alert System of Food and directly at food establishments such as restaurants. This Feed (RASFF), imported products that do not comply Comparative Analysis of Certain Requirements of Food Legislation in the European Union 54 and the Customs Union of Russia, Belarus, and Kazakhstan with the labeling requirements are not rejected: usually While one of the keys to marketing a product can be the missing or incorrect information can be corrected the use of various voluntary food safety management by, for example, attaching an additional sticker to the standards logos and marks on a product label, as it label. Because the Customs Union technical regula- may instill consumer confidence in the product, food tion CU TR 022/2011 on food labeling has just come in business operators must recognize that the use of full force (transition period for its application ended on “HACCP Certified” or its analogs is not acceptable in the February 15, 2015), it is not clear how such issues will be European Union, and the use of certification marks “ISO addressed. It is not likely that attaching a sticker would 22000:2005 certified” is against international practice be a common solution, as in such case additional is- and ISO rules. Alternatively “HACCP Certified” is accept- sues with regard to conformity assessment of the sticker able in the Customs Union and is quite often found on according to CU TR 005/2011 “On Safety of Packaging” food product labels. may arise. For industries wishing to provide products to the EU At the level of specific labeling requirements the dif- food service market (which is a significant target market) ferences between the Customs Union and European they must comply with the general and specific food Union are quite numerous and therefore before in- labeling laws and regulations of the European Union. dustry places a product in the respective market they Alternatively, if the industry wishes to supply to the must ensure that the products labels conform to the food service market in the Customs Union, the label- specific requirements. Further, industry must recognize ing requirements will depend on the type of packag- that compliance with one trading bloc does not ensure ing (consumer or transport packaging), and food service compliance with the other. This will entail some addi- businesses do not have to provide information to con- tional investments into development and production of sumers under CU TR 022/2011. market-specific labels. Requirements to Food Labeling in the European Union and the Customs Union 55 Comparative Analysis of Certain Requirements of Food Legislation in the European Union 56 and the Customs Union of Russia, Belarus, and Kazakhstan Food and Food-related Articles and Materials that Require Special Authorization standards is significant and detailed. While this executive summary and the in-depth companion document sum- marize the most important issues and details, it should be noted that the number of nuances for every sub- stance, material or article that business operators may wish to export to either market is massive. Therefore it is Executive Summary especially important for business operators prior to ex- The Customs Union and the European Union have es- porting a product or material to either Union that they tablished that there are types of food, classes of sub- undertake a specific review of the relevant laws, guid- stances and/or materials that when either added to food ance documents, and technical regulations. Further, it or come in contact with food require special authoriza- must be noted that compliance with the Customs Union tion to be placed on the market and shall meet special or the European Union does not necessarily confer requirements to ensure food safety. These include novel compliance with the other as the specifics differ signifi- food, food supplements, food additives and packaging cantly between the two Unions. For example, in the area and articles and materials in contact with food. Novel of food additives, of the 500 or so food additives that are food basically is food produced with completely new included into the EU and CU lists, there are 43 which untraditional technologies or being absolutely unfa- are approved for use in the Customs Union but not in miliar to consumers. Dietary supplements also require the European Union. Similarly, there are 19 food addi- special authorization as they are consumed to improve tives which are approved for use in the European Union the health and well-being of consumers. Food additives which are not approved for use in the Customs Union. which are chemicals specially added to food to improve its taste, flavor or color, or to enable technological pro- These topic areas are not static and undergo changes as cesses shall also go through authorization procedure to new information, new materials, new substances and establish their safety. Food packaging and food contact technologies are made available. Due to the ever chang- materials as they have the potential to leach chemicals ing environment of the regulatory systems, lists of ap- into the food shall be tested first to establish they are proved and not approved substances change overtime food-grade. Governments and consumers are con- which requires that companies continue to monitor cerned with the possible human health effects of these these areas and review the specifics prior to developing substances and materials and therefore they are treated a product and exporting to either of the trade Unions. separately under each Union’s regulatory environment. For governments wishing to model or harmonize with These are broad groups of substances, materials and ar- either the Customs Union or the European Union this is ticles that require authorizations; each group has its own possible and practical. Harmonization will take signifi- laws and technical regulations, scopes of the regula- cant time and effort as both Unions have complex and tions, definitions, authorization procedures, and specific detailed regimes for these subject areas. What is not pos- requirements. This makes each area unique and requires sible is the simultaneous harmonization to both Unions a separate discussion for each general topic. Further, as the approach and specific differences between the while it is possible to conduct a comparative analysis Customs Union and the European Union are significant between the European Union and the Customs Union enough to render this impractical and impossible. for novel foods and food additives as the scopes of le- gal acts are similar, in the cases of dietary supplements For governments evaluating modeling or harmonization and food contact materials the scopes of the laws be- with either Union there are two key differences that they tween the Customs Union and the European Union are should note. The Customs Union regulatory system is fo- significantly different and therefore a direct one-to-one cused on the use of conformity assessment (for foodstuffs comparative analysis could not be fully conducted; the - in the form of conformity declaration). The conformity approach to analysis was modified in order to provide assessment is based on ensuring food safety through the the appropriate information for business operators and use of testing to determine if the final foodstuffs meet a governments. specific technical specification. The European Union sys- tem is based upon a risk-based approach from farm-to- These areas are highly technical and complex. The body fork where risks are identified, mitigated, and controlled of laws, regulations, directives, technical regulations and through preventive methods, and the role of enforcement Comparative Analysis of Certain Requirements of Food Legislation in the European Union 58 and the Customs Union of Russia, Belarus, and Kazakhstan regime is to verify that the controls are effective. This dif- environment. The European Union requires that prior to ference becomes apparent especially in the specific topic authorization to place such substance, material or article areas of novel foods, food additives, dietary substances, on the market it must be preceded by an independent and food contact materials as it creates significant differ- scientific risk assessment of the highest possible stan- ences in the approach between the Customs Union and dard for the risks that the substance, material or article the European Union to authorization and introduction of can pose to human health, with an opportunity for all new materials and technology. EU members to rise their concerns; this lengthens the authorization process. Further, when conducting the The second systemic difference between the Customs evaluation other legitimate factors relevant to the mat- Union and the European Union which is especially ob- ter are taken into consideration including societal, eco- vious when it comes to special authorizations is in the nomic, traditional, cultural, ethical and environmental details of intent. At a high level the intent of both Unions factors and the feasibility of controls which can lead is the same: to protect consumer health and well-being; to specific requirements for controls, imposing limita- to ensure free movement of goods within the respective tions on amounts of materials used, specific restrictions Unions; to protect consumer from being misled; and to in applications, and labeling. Finally, such substances, protect the environment. These intents are common to materials, and articles should be kept under continuous both Unions and in general are basic for governments to observation and must be re-evaluated whenever neces- meet the needs of their people. However, the differenc- sary in the light of changing conditions of use and new es lie in what goes after these general high-level intents. scientific information which sets the stage for continu- ous change that can impact not only the authorization The Customs Union law does not specify any further status, but also how they are used and in what quanti- intents or considerations. The European Union further ties. These specific detailed intents are some of the rea- elaborates its intent to include such areas as transparen- sons why there are significant differences between the cy in the production and handling of food which drives Customs Union and the European Union in the details the requirements for traceability within the regulatory of the respective regulatory environments. Novel Food Globalization of the food supply chain, search for new items in this category of novel foods into the market products and tastes have led to development and use place1,2. of new ingredients and technologies in the food sec- tor. New ingredients from Africa, Asia and Latin America At a high level the scope and definitions of novel food are have added new flavors, colors, and tastes to the food similar in the CU and EU: they broadly cover foodstuffs industry repertoire creating a variety of new and unique which have not been used for human consumption to a food products. Advances in science and technology significant degree within the marketplace previously. The such as nanotechnology offer new ways to improve scopes of novel food regulations in both Unions encom- food safety through packaging and food treatments. For pass food with new or deliberately modified primary each new ingredient, flavor, color, and technology that molecular structure. The scopes include foods consisting is applied to food there are concerns as to the influence of or isolated from microorganisms, fungi or algae, plants and impact these will have on human health. One of the and animals. However, there are differences which are primary roles of government in both Unions is to protect important to understand for industry wishing to export to consumers from harm, product adulteration and being either Union and for governments that intend to harmo- misled, and therefore both Unions have established spe- nize with one or the other of the Unions. Key differences cific legal provisions to govern the introduction of foods between the Customs Union and the European Union 1 European Union: Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. 2 Customs Union: novel food falls under the scope of CU TR 021 “On Food Safety” as one of its objects of regulation. In particular, defini- tion of “novel food” (or, as sometimes translated, “food of a new type”) is given in Article 4, and further rules are outlined in Article 27 (State registration of novel food) and Article 28 (Procedure for state registration of novel food) that directly deal with novel food. Food and Food-related Articles and Materials that Require Special Authorization 59 include how each of the Unions considers the following genetically modified organisms, use within the territory, elements of the scope of regulatory requirements: the new production processes, nanomaterials, and novel inclusion/non-inclusion of food ingredients, food addi- food/food ingredients used in food supplements (sum- tives and flavorings, extraction solvents and enzymes, marized below in Table 1). Key Differences in the Scope of Regulatory Requirements on Novel Food between the Table 1 Customs Union and the European Union Topic Area Customs Union European Union 3 Food Ingredients Food ingredients not directly Includes novel food and novel food ingredients included; the scope includes only food Food additives and Included Excluded and are subject to separate regulations4,5 flavorings Extraction solvents and Not clearly specified but can Excluded but are subject to separate regulations7,8 food enzymes be interpreted as included6 Genetically modified Included No longer included but are subject to separate organisms regulations9 Use within territory10 Covers items not in use Covers items that were not in use to a significant within the area of the degree within the Community before May 1997 Customs Union New production process Not Included Includes food produced through new production processes that substantially change its composition Nanomaterials Specified as a type of novel Falls under the category “new production process” 11 food Novel food/food ingredients Not included Foods and/or food ingredients were used exclusively used in food supplements in food supplements, new uses in other foods require authorization 3 Refer to notes 1 and 2. 4 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. 5 Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavorings and certain food ingre- dients with flavoring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC. 6 In the Customs Union, food enzymes and extraction solvents should fall under the definition of “novel food” and the scope of the CU novel food rules, because they are covered by the general definition of “food product” established by the same technical regulation CU TR 021/2011. 7 Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients. 8 Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97. 9 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. 10 Limiting the scope to the use within certain territory is an important difference because food habits, traditions and technologies may vary significantly between countries and traditions, and a food item that has already become consumed within one area may be novel to the other area. It is important that neither the European Union nor the Customs Union recognize authorizations of novel food from other countries or regions valid within their territories. 11 This is a demonstration of how flexibility and broad category identification works. EU Regulation 258/97 was adopted in 1997, while engi- neered nanomaterials` (ENM) first came into spotlight of European Food Safety Authority (EFSA) only in 2006; legal definition of engineered nanomaterials was established only in 2011 by Regulation (EU) 1169/2011 on Food Information to Consumers. Still, because of the way the EU Novel Foods Regulation was designed back in 1997, it allows to include the ENM into its scope. It should be noted that in 2011 EFSA adopted Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain, as it is deemed that a more serious toxicological study of ENM safety is needed. The Guidance is available at http://bookshop.europa.eu/is-bin/ INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=TM3012980. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 60 and the Customs Union of Russia, Belarus, and Kazakhstan With respect to the future, as new technologies (ingre- or incorporated into food such ingredients and food are dients and processes) are developed there are differ- subject to the provisions of the European Union novel ences in how these can be regulated by each Union. food regulations. Therefore for industry wishing to ex- The Customs Union approach to defining novel foods port to either Union it is important to determine if the is through the use of an exhaustive definition which im- use of the new technology falls within the scope of the plies, based on the Customs Union legal framework, that novel foods regulations prior to introduction into the only foods that have the described characteristics within market place. the specific novel foods definition can be recognized as novel. This implies that in cases where new technol- Prior to placing a novel food in the marketplace both ogy or food incorporating the new technology does not Unions have an authorization process which includes have the characteristics described in the Customs Union rules for placing the food on the market and suspen- specific novel foods definition, these foods may not be sion. Further both Unions have provisions on maintain- considered novel and therefore are not subject to the ing a novel food Catalogue and lists of authorizations/ specific Customs Union novel food requirements12. The registrations and notifications. Table 2 summarizes key European Union has offered a definition of novel food requirements within both Unions for authorization (reg- but instead identified criteria and categories of products istration), suspension and cataloguing novel foods. It is that fall under its scope, and as one of the criteria of important to note that there are differences between the “novelty” lists new processes technologies; as new in- two trading Unions which can be found by comparing gredients and processing methods are developed and/ the highlighted requirements in Table 2. Highlighted Requirements within the Customs Union and European Union for the Registration, Table 2 Suspension and Cataloguing of Novel Foods Topic Customs Union European Union Must go through state registration. Must go through authorization. Through registration, foodstuff is assessed Through authorization, foodstuff (foods and food against a criteria of food safety. ingredient) is assessed against the following crite- ria: must not present a danger for the consumer, Once registered, such food item will not be Rules for Placing mislead consumer, nor be nutritionally disadvan- considered novel food in the future, and the Food on the tageous for consumer. will not be subject to state registration by Market another applicant and under other names. Once authorized, is still considered novel but does After the novel food item is registered, it not require authorizations by other applicants. is subjected to the general rules of con- Once authorized, will be monitored and formity assessment adopted and has no re-evaluated. expiration date. 12 It is important to note that at the time of writing of this report the Customs Union had not registered any novel foodstuffs and therefore interpretation of new technologies within the novel food definition and rules has not been demonstrated, making this an area for future interpretation. Food and Food-related Articles and Materials that Require Special Authorization 61 Topic Customs Union European Union Registration/ To obtain a state registration of novel food, EU law establishes 3 types of permissions which Authorization an applicant shall submit an application and vary by requirements (more specifically, by risk Process documentation that confirms safety of such assessment procedure). products that includes: results of examina- Permission based on initial assessment13. For tion (testing) of the samples of novel food products being placed on the market for the products that were carried out in an ac- first time the request shall contain a copy of the credited testing laboratory, as well as other studies and any other material which is available documents confirming safety for human life to demonstrate that the food or food ingredient and health; and information, obtained from complies with the criteria and appropriate any reliable sources, about their impact proposal for the presentation and labeling. on human body confirming absence of Permission by authorization decision14. adverse health effects. Authorization decision shall be taken where an No information during the registration additional assessment is deemed necessary and process is communicated to other Customs requires that such additional assessment is carried Union member states. out by the European Food Safety Authority (EFSA). The risk assessment must demonstrate that these products do not pose any risk to health or the environment. Permission through notification15. A simplified procedure is applied to certain types of novel food and food ingredients that do not require a risk assessment. Can only be used if items are: foods and food ingredients consisting of or isolated from micro- organisms, fungi, algae, and plants; food ingredients isolated from animals; are substantially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein; and the equivalency is supported by scientific evidence available and generally recognized or on the basis of an opinion delivered by one of the competent bodies designated by member states. In any of the three permission types, all EU member states receive communications during the authorization process and can raise concerns or ask additional questions Responsible Agency on State Registration of Novel Bodies responsible for approvals and authoriza- Bodies Foods16 tions of novel foods and ingredients include both nationally designated authorities and the European Commission Risk Assessment Implied but not specifically addressed as Importance of risk assessment is emphasized. a part of The Agency for Registration of The procedure provides for a notion of equiva- Novel Foods review of the application lence to existing foods and food ingredients, and documentation in certain cases a risk assessment has to be carried out by EFSA 13 Regulation (EU) 258/97, Articles 4 and 6. 14 Regulation (EU) 258/97, Articles 7 and 8. 15 Regulation (EU) 258/97, Articles 3(4) and 5. 16 At the time of writing this body had not been established Comparative Analysis of Certain Requirements of Food Legislation in the European Union 62 and the Customs Union of Russia, Belarus, and Kazakhstan Topic Customs Union European Union Suspension State registration of novel foods may be ter- Member States are authorized to suspend or Procedure minated or suspended only by the Agency restrict provisionally the marketing and use in on State Registration of Novel Foods in their territory of any novel food or food ingredi- cases of infliction of harm revealed in the ent if they believe that its use constitutes a health course of state control (surveillance) and hazard or a risk to the environment. upon decision of judicial authorities of the Customs Union member-state Novel Food At the time of writing, a Unified Register The Commission maintains a separate list of Catalogue of Novel Foods has not been publically authorizations17 and notifications18 on novel foods and Lists of established and ingredients. In addition, there is publically Authorizations accessible database which contains information and Notifications on all items including those that have not been authorized; the data base is called “Novel Food catalogue19” it is a living database but has no legal status. Duration of the 5 business days No time frames established; in practice, can take Registration/ up to 2 years Authorization Procedure Recently, in European Union a draft regulation was pro- If a history of safe food use can be demonstrated in a posed to repeal Regulation (EC) No 258/97 on Novel third country and there are no food safety objections Foods. It calls for the creation within the European from the European Food Safety Authority (EFSA) or EU Union of a centralized authorization system and to en- Member States the food will be allowed to be placed on hance application of risk assessment to novel foods. the European market on the basis of a notification from The new draft was developed to provide greater clar- the third country’s food business operators20. It is unclear ity and to simplify the authorization process for appli- if/when the new draft Regulation repealing Regulation cants. Further the proposed regulation also introduces 258/97 will be adopted; until then, the current rules are an authorization process for foods, which are new in the in force. European Union but are traditional in other countries. 17 The EU list of authorizations of novel foods and food additives can be accessed at http://ec.europa.eu/food/food/biotechnology/ novelfood/authorisations_en.htm 18 The EU list of notifications on novel foods and food additives can be accessed at http://ec.europa.eu/food/food/biotechnology/novelfood/ notif_list_en.pdf#page=71 19 The Novel Food Catalogue can be accessed at http://ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/mod_search/index. cfm. 20 This information has been taken from the web-site of Lex Alimetaria http://www.lexalimentaria.eu/ing/news/75-reform-of-eu-regulation- on-novel-foods-a-step-forward-.html. Food and Food-related Articles and Materials that Require Special Authorization 63 Dietary Supplements It is important to note that within legal acts of the Customs Information to Consumers; but the current health claims Union and the European Union with regard to substanc- rules will stay in force). es that can be described broadly as dietary supplements there are significant differences in terminology used. The While a direct comparison of biologically active supple- differences are significant enough that it does not allow ments (Customs Union) and food supplements (EU) be- the establishment of a strong correlation between the tween the Unions cannot be made it is important that two regulatory environments and therefore the ability to industry and governments have an understanding of conduct a direct comparative analysis is not possible. what process are required to place biologically active sub- stances (Customs Union) or food supplements (European In the European Union, relevant laws and regulations21 Union) on the market. focus on concentrated sources of two types of nutrients: vitamins and minerals that are marketed and sold sepa- Within the Customs Union biologically active substanc- rate from the food product; these are called food supple- es are registered according to Technical Regulation CU ments. In the Customs Union22 the focus is on a broad TR 021/2011, and more specifically, several standards range of substances that are added to food or consumed referred to in the Technical Regulation as control tools: separately and are called biologically active supplements GOST R 4.1.1672-03 “Guidance on methods of control (BAS); no specific provisions focused only on vitamins and of quality and safety of biologically active food supple- minerals exist. The Customs Union definition of BAS in- ments” and Methodological Guidelines MUK 2.3.2.721- cludes food fibers, pollen, fish and marine species, algae, 98 “Determination of safety and efficacy of biologically probiotic microorganisms, meat and milk raw materials, active food”. Only those biologically active supplements proteins, amino acids and their complexes, vegetable that have successfully completed state registration can be oils, animal and vegetable lipids, as well as vitamins and placed on the market; registration also covers produc- minerals. For most of the Customs Union’s biologically tion (manufacturing), storage, shipment (transportation) active supplements there are no corresponding specially and sale. Registration procedure requires that a complete focused legal acts in the European Union. Depending package of documents is submitted to the Agency for on the type of the material used in the Customs Union’s Registration of Specialized Food Products, including: BAS, these may be fully or partially covered under EC  an application in an established format; Regulation 258/97 on Novel Foods and Food Ingredients.  the results of examination (testing) of samples of In addition, depending on the Customs Union’s BAS biologically active supplements carried out in an origin and nature, their use in food, and claims that are accredited testing laboratory; to be made on the label, there may be corresponding  other documents confirming safety and confor- requirements in the EU Regulation (EC) No 1924/2006 mity of such products to the requirements of ap- on nutrition and health claims made on labels (note: in plicable Customs Union technical regulations; and December 2016, new rules on nutrition claims will enter  information about the intended use. into force based on Regulation (EU) 1169/2011 on Food 21 In the European Union, the regulated area covers “food supplements” (not to be confused with “food additives”). According to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, food supplements are defined as “concentrated sources of nutrients (vitamins and mineral salts) or other substances with a nutritional or physiological effect, alone or in combination, which are marketed in dose form (e.g. capsules, tablets, sachets, etc.) in order to supplement a normal diet”. Effective legal acts on food supplements cover only vitamins and minerals. 22 Within the Customs Union, technical regulation 021/2011 “On Food Safety” contains the definition of “biologically active supplements” (or, in some translations, “biologically active additives”), which are “natural and (or) identical to natural biologically active substances, as well as probiotic microorganisms, intended for consumption together with food or mixing into food products”. These biologically active supplements/additives can be viewed broadly as dietary supplements beyond vitamins and minerals which are used for the production of enriched food. Biologically active supplements/additives include plants or plant extracts, animal origin substances, microorganisms, fungi, etc. They belong to specialized food products, and can be based on vitamins and mineral substances, but also on food fibers, pollen, fish and marine species, algae, probiotic microorganisms, meat and milk raw materials, proteins, amino acids and their complexes, vegetable oils, animal and vegetable lipids, etc. These types of BAS are listed in point 1.9 of Annex 2 “Microbiological safety criteria” of CU TR 21/2011. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 64 and the Customs Union of Russia, Belarus, and Kazakhstan Upon successful submittal of the completed document Within the European Union approved food supplements package consideration of documents is to be finalized are regulated by Directive 2002/46/EC of 10 June 2002 within 5 business days. If approved, information about on the approximation of the laws of the Member States the name of the biologically active supplement and relating to food supplements. Only vitamins and miner- its applicant will be entered in the Unified Register of als fall under food supplements; moreover food supple- Specialized Food Products and like other specialized ments may only contain the vitamins and mineral salts food products, the registrations has no expiration date. laid down in Annex I of the Directive, and the vitamin and If denied the applicant will be notified23. State registra- mineral formulations listed in Annex II of the Directive, tion may be terminated or suspended by the Agency singly or in combination. The presence of vitamins and for Registration of Specialized Food Products in case of minerals in any of the two Annexes means they are non-conformity to the requirements of the present tech- authorized. No additional authorization is required by nical regulation revealed in the course of state control, the EU law; however, to facilitate efficient monitoring and upon decision of judicial authorities of the Customs of food supplements, member states may require the Union member state. manufacturer or the person placing the product on the market in their territory to notify the competent authori- The Customs Union technical regulation CU TR 021/2011 ty of that placing on the market by forwarding it a model establishes certain limits for the amount of biological- or example of the label used. ly active supplements when they are part of enriched foodstuff. In particular, the amount of each biologically The European Union Commission is responsible for es- active supplement used for enrichment in enriched food tablishing the purity criteria for substances contained in products shall be brought to the level of consumption in food supplements as well as the maximum and mini- 100 ml or 100 g or a single serving of such products of at mum quantities authorized. As excessive intake of vi- least 5 percent of the daily intake’s level (CU TR 021/2011, tamins and minerals can result in adverse effects, the Article 7 (12)). The amount of biologically active supple- Directive provides a possibility to establish a maximum ments derived from plants and (or) their extracts in a total safety level in food supplements designed to ensure that BAS daily dose shall range from 10 to 50 percent of the consumers will not ingest too high a dose of the par- amount of their single therapeutic dose defined for the ticular vitamin or mineral under normal use. The dos- use of such substances as medicines. These are further age amounts have not been set at the EU level yet, but delineated for biologically active supplements for food the process to develop these levels has begun. On this for children aged between 3 and 14 years and herbal teas clause, a special ruling of the European Court of Justice for infants; for infants it is only allowed to use plant raw (ECJ) was adopted in 2010. The ECJ ruled that, so long materials specified in Annex 824 of the CU TR 021/2011 as the Commission has not set the upper safety limits for (Article 8(10). The CU TR 021/2011 also excludes the use food supplements, Member States remain competent of biologically active supplements from certain plants or to adopt legislation on those limits. In doing this, they products of their processing, species of animal origin, must use the principles of risk assessment. Moreover, in microorganisms, fungi, or biologically active substances the absence of limits established by the Commission, that pose a health risk to humans and animals (listed in member state can establish a maximum amount of cer- Annex 7 of CU TR 021/20011 (Article 8 (11)25. Finally, bio- tain substances as a zero level, virtually restricting such logically active supplements should conform to hygiene supplements on their territory26. requirement of food safety (Annexes 1, 2, and 3 of CU TR 021/2011) as well as specific microbiological criteria and The EU Member States may not prohibit or restrict trade maximum levels of chemical contaminants, mycotox- in food supplements which comply with this Directive, ins, banned pesticides, dioxins, melamine and nitrates. except where they find that the products pose a public 23 The legal acts of the Customs Union do not articulate if there is an appeals process or if appeals are possible. 24 Annex 8 Species of Plant Raw Materials for Manufacturing of Biologically Active Food Additives for Children from 3 to 14 Years Old and Baby Herbal Teas (Herbal Drinks) for Infants. 25 Annex 7. List of Plants and Products of their Processing, Species of Animal Origin, Microorganisms, Mushrooms, and Biologically Active Substances, Prohibited for Use as Part of Biologically Active Food Additives. 26 See Case C-446/08 by the European Court of Justice, published at Lex Alimetaria http://www.lexalimentaria.eu/ing/attachments/034_ ECJ-446-08.pdf. Food and Food-related Articles and Materials that Require Special Authorization 65 health risk. Where such risk occurs, a Member State may not mean they are not regulated in member states. temporarily suspend or restrict application of the provi- The member states have national laws regulating sub- sions of the Directive27. stances other than vitamins and minerals in food sup- plements. For example, in 2012 Italy adopted a Decree Food supplements may not include claims such as pre- on Food Supplements Containing Herbal Substances venting, treating or curing human disease. When includ- and Preparations which established a list of permitted ing such claim on a product, it is no longer considered herbals in the manufacturing of food supplements; this a food supplement, but a medicinal product and must Decree mirrored similar legal acts adopted in Spain and meet another set of requirements. Denmark29. With regard to use of substances other than vitamins In the EU, Health claims are a significant part of the re- and minerals in food supplements, in 2008 a special quirements related to food supplements. Within the EU, Report was published by the EU Commission28. The Regulation (EC) 1924/2006 on nutrition and health claims Commission concluded that the existing Community made on foods30 lays down harmonized rules across the legal instruments are satisfactory. Consequently, it is European Union for the use of nutrition claims such as not necessary to lay down specific rules for substances “low fat”, “high fiber” or health claims such as “reducing other than vitamins or minerals for use in food supple- blood cholesterol”. Health claims have to be substanti- ments. The market for food supplements is extremely ated by generally accepted scientific data. The health varied from one Member State to another. The use of claims can be made not only on food supplements but these substances is therefore subject to the rules in on other substances as well as long as they are part of force in national legislation without prejudice to any food intended for final consumers. Health claims cannot other Community provisions which are applied to them. be made on foodstuffs as a whole, only on a substance However, the Commission does not rule out the possi- contained in the food; foods bearing claims that could bility of carrying out a supplementary analysis, examin- mislead consumers shall be eliminated from the market. ing the conditions for the addition of these substances The rules for making health claims are detailed, and it is to foodstuffs in general, since they are now being added important to note that for most of vitamins and minerals to ordinary foodstuffs. as food supplements, certain health claims are already registered, including specific conditions of their use. The fact that substances other than vitamins and min- Such claims can be found in the EU Register of Nutrition erals are not regulated at the Community level, does and Health Claims Made on Foods31. 27 For the details, see Article 12, Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. 28 Report from the Commission to the Council and the European Parliament of 5 December 2008 on the use of substances other than vitamins and minerals in food supplements COM(2008) 824, http://ec.europa.eu/food/food/labellingnutrition/supplements/documents/ COMM_PDF_COM_2008_0824_F_EN_RAPPORT.pdf 29 Lex Alimentaria, http://www.lexalimentaria.eu/ing/news/69-italy-pushes-forward-restrictions-on-botanicals-in-food-supplements.html 30 Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. 31 http://ec.europa.eu/nuhclaims/ Comparative Analysis of Certain Requirements of Food Legislation in the European Union 66 and the Customs Union of Russia, Belarus, and Kazakhstan Food Additives Food additives are substances added intentionally to usually approved for use under certain conditions, in foodstuffs to perform certain technological functions, particular, for specific foodstuffs only, and in a certain for example to color, to sweeten or to help preserve amount. In some cases, usually for certain traditional foods. Food additives such as vinegar, salt and sugar foodstuffs no food additives are allowed. have been used for centuries to assist for such purposes. Until the 20th century there were relatively few kinds There are other substances more or less similar to food of additives, but during the last hundred years with a additives and often confused with food additives, e.g., dramatic development of food industry there has been flavorings, food enzymes, processing aids. In most cases a significant increase both in the number and usage of they are not assigned with an “E” number and in some food additives. cases do not require a safety assessment, but still there are rules for using them in food production. Food additives are only permitted if they are deemed safe and perform useful functions (many additives fre- At a high level the regulations of food additives within quently have more than one function). Food additives the Customs Union and European Union are similar in that are deemed safe based on the best scientific knowl- intent and purpose. The significant differences between edge available are approved for use, receive approval the Unions can be found in the specific details of the numbers and are identified both by these numbers and control processes and in the specifics of which prod- by their names. In many regions of the world includ- ucts are approved for use. The rules concern not only ing the European Union and Customs Union, it is com- manufactures of food additives but also food processors mon to see food additives identified with an E number32. who use food additives in their products. These specif- Importantly, with the growth of consumer awareness, ics are important to companies wishing to export food food additives E-numbering, has become recognizable products to either Union as approval of a food additive in by consumers. It is critical to understand that E-numbers one Union does not infer approval in the other. One of were first introduced in Europe and are used to indicate the most common reasons for foodstuffs being denied food additives that are permitted in the European Union. entry into the European Union is presence of unauthor- However, it is not uncommon for food additives that ized food additives.33 For governments the specifics of have lost their approval in the EU (and, consequently, the registration/authorization of food additives, control their “E”), still bear the “E” in other countries. over their use and suspension of authorizations are im- portant as the differences between the two Unions are For many consumers “E number” has a negative con- significant and therefore simultaneous harmonization to notation with something chemically unnatural to food, both Unions is not practical. if not poisonous. However, some additives with E num- bers are common and familiar substances. For example, The intent and purpose of food additive regulatory con- vitamin C is approved as E300. Some food additives trol in both Unions at a high level is the same in that have natural origin; others are synthetic and artificially within the Customs Union and European Union the ob- produced. Those that are of natural origin can be de- jectives are the protection of consumer health and life, to rived from animal or plant sources, which is important establish common requirements within their respective for groups of consumers with specific religious, cultural trading block, to ensure the free movement of goods, or ethical needs. protect consumers from being misled, and environmen- tal protection. Due to the historical nature of the use of Each additive is expected to be of a standard compo- food additives and existence of national rules in mem- sition, and this is ensured by developing specifications ber states of each Union prior to formation of a respec- and purity criteria for food additives. Because food ad- tive common market, there is an inherent complexity ditives are supposed to have a targeted effect, they are in both Unions in this area of regulatory control, which 32 However, other numbering systems exist as well, and, for example, in the Customs Union it is acceptable to identify food additives on the food labels by E number or by INS number (this numbering system is maintained by Codex Alimentarius Commission). 33 The Rapid Alert System for Food and Feed 2013 Annual Report, http://ec.europa.eu/food/safety/rasff/docs/rasff_annual_report_2013.pdf Food and Food-related Articles and Materials that Require Special Authorization 67 makes a comparative analysis complex. This complexity scope, the European Union regulations of the so called is made more difficult as the control mechanisms of the Package on Food Improvement Agents does not con- two Unions are significantly different, and to add to the tain any such requirements, because food additives, complexity, the definitions of classes of food additives enzymes and flavorings fall under the definition of differ. Finally the specific food additives that are allowed “food” and aspects related to production, transporta- or not allowed in each Union differ as well. Therefore tion, storage, etc. are regulated by the Regulations of the authors have provided a simplified comparison of the Food Hygiene Package (in particular, EC Regulations the similarities and differences between the Unions but 852/2004, 853/2004,854/2004). recommend that for companies and governments read- ing of a more in-depth analysis will be required to fully The definition of food additive used in the European understand the specifics of each Unions’ approach and Union regulations and in the Customs Union CU TR details related to each food additive. 029/2012 are equivalent. At the same time, EU Regulation 1333/2008 lists a number of exclusions from the defini- The scope of the regulatory requirements of food ad- tion of food additive37 that refines the scope of the defi- ditives is similar between the Customs Union34 and the nition. For example, in the European Union substances European Union35; in both cases it covers similar areas: should not be considered as food additives when they authorization, establishment of community lists, condi- are used for the purpose of imparting flavor and/or taste tions of use of the food additives, including maximum or for nutritional purposes, such as salt replacers, vita- levels and food categories to which food additives can mins and minerals. Moreover, substances considered be applied, labeling and specifications and purity cri- as foods which may be used for a technological func- teria. However, it does not mean that inside each area tion, such as sodium chloride or saffron for coloring and specific requirements are similar. The key difference be- food enzymes should also not fall within the scope of tween the two Unions is that the European Union le- Regulation 1333/2008. Such and other nuances do not gal requirements do not cover processing aids (except become clear from the definition of food additive es- when processing aids are food enzymes); while in the tablished in the Customs Union; one needs to carefully Customs Union processing aids are directly mentioned check the text of CU TR 029/2012 and all annexes to as one of the objects of technical regulation. Also, while determine if an ingredient is or is not a food additive. the Customs Union Technical Regulation 029/201236 establishes requirements to production, storage, trans- An important note must be made on two terms widely portation, sale and disposal of the substances within its used in the EU and the Customs Union legal acts on 34 In the Customs Union the scope of the regulatory requirements on food additives is established in technical regulation CU TR 029/2012 “Safety Requirements for Food Additives, Flavorings and Technological Aids”. 35 On 16 December 2008, the regulations of the so called Package on Food Improvement Agents were adopted (Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorization procedure for food additives, food enzymes and food flavoring; Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97; Regulation (EC) no 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives; Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC). Importantly, the Regulations of the Package on Food Improvement Agents replaced earlier existing directives, which significantly changed the set of sector-specific legal requirements that existed earlier in the EU and increased the level of harmonization between the member states. The regulations have also been sup- ported with implementing legal acts (called “implementing regulations”). 36 Technical Regulation of the Customs Union CU TR 029/2012 “Safety Requirements for Food Additives, Flavorings and Technological Aids” . 37 The following are not considered to be food additives in the European Union: (i) monosaccharaides, disaccharides or oligosaccharides and foods containing these substances used for their sweetening properties; (ii) foods, whether dried or in concentrated form, including flavorings incorporated during the manufacturing of compound foods, because of their aromatic, sapid or nutritive properties together with a secondary coloring effect; (iii) substances used in covering or coating materials, which do not form part of foods and are not in- tended to be consumed together with those foods; (iv) products containing pectin and derived from dried apple pomace or peel of citrus fruits or quinces, or from a mixture of them, by the action of dilute acid followed by partial neutralization with sodium or potassium salts (liquid pectin); (v) chewing gum bases; (vi) white or yellow dextrin, roasted or dextrinated starch, starch modified by acid or alkali treat- ment, bleached starch, physically modified starch and starch treated by amylolitic enzymes; (vii) ammonium chloride; (viii) blood plasma, edible gelatin, protein hydrolysates and their salts, milk protein and gluten; (ix) amino acids and their salts other than glutamic acid, glycine, cysteine and cystine and their salts having no technological function;(x) caseinates and casein; (xi) inulin. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 68 and the Customs Union of Russia, Belarus, and Kazakhstan food additives, because these terms do not seem to be corresponding, but in fact are. The terms are “quantum satis” (EU) and “in accordance with technical documen- tation” (Customs Union). There are cases where no legal maximum limits are established for the use of food additives or other sub- stances used for technological purposes in foodstuffs. In such situations the European Union law prescribes to follow the principle of “quantum satis”, which in Latin means “the amount which is needed”. In the same situ- ation, the Customs Union CU TR 029/2012 prescribes to follow “technical documentation” which has to be avail- able from the food additive manufacturer, and where, in the absence of legal maximum limits, the manufac- turer maximum limits are established. The manufacturer, when establishing such recommended limit, shall take into account that the substance must not exceed the levels necessary for achieving a technological effect. The key difference is that according to the European Union regulations, a food processor takes the decision Quantum satis and responsibility to decide the amount of such sub- stance which is to be added. According to the Customs It has its origins as a quantity Union rules, even if no limit is established in technical specification in medicine and regulations, a food processor cannot decide how much pharmacology, where a similar term to use; he has to refer to manufacturer’s technical docu- quantum sufficit has been used mentation for the substance in question. (abbreviated Q.S.). Essentially it means “Add as much of this ingredient as is The authorization and use of food additives is regulated needed to achieve the desired result, by both Unions. The specifics of each are quite differ- but not more.” ent and impact companies wishing to export to either trading Union. The Customs Union requires that food additives placed on the market and used by food processors be from the list of authorized substances made part of CU TR 029/2012; that food additives must have successfully passed state registration38 and be accompanied by a 38 According to Decision No. 880 of the Customs Union Commission of December 9, 2011 “On Adoption of the Technical Regulation of the Customs Union “On Food Safety” , the follow- ing substances (food additives, complex food additives, flavor- ings, plant extracts as flavoring substances and raw materials, starter cultures of microorganisms and bacterial starter cultures, processing aids, including enzymes) are subject to state regis- tration according to the rules applied to specialized food. State registration is one of the forms of conformity assessment used in the Customs Union. The substances shall be subject to state registration in the manner provided in Article 24-26 of CU TR 021/2011, and the registration shall be completed by February 15, 2015. It is expected that by that date all substances currently in use will pass state registration Food and Food-related Articles and Materials that Require Special Authorization 69 declaration of conformity issued by each manufacturer the relevant safety criteria. It is important to note of food additives or an authorized representative within that this regulation does not apply to the registra- the territory of the Customs Union. tion of new food additives and to updating the list of approved food additives; instead it applies to new manufacturers, importers or distributors of There are several key points about the authorization an existing approved food additive. of food additives in the Customs Union that should be  Food additives and flavorings, may be novel, and highlighted. as such, novel food additives and flavorings are  Neither CU TR 029/2012 nor Uniform Sanitary, subject to the authorization rules for novel food. Epidemiological and Hygiene Requirements es-  As for the food additives and flavorings, they are tablishes a process or procedure for authorization subject to conformity assessment by means of of new food additives. Therefore it is unclear as declaration of conformity which differs based on to the process for authorization of new food ad- the type of production and laboratory used for ditives that are developed in the future. testing41. Note that the time validity for the decla-  As food additives and flavorings are included in ration of conformity is established by an applicant the definition of “food products” established by but, depending on the declaration scheme, has CU TR 021/2011 “On Food Safety”39 requirements certain limits. and procedures established to food products  The state control (supervision) for compliance apply to food additives and flavorings including with the requirements of the Technical Regulation conformity assessment, CU TR 029/2012 refers CU TR 029/2011 shall be carried out according to relevant articles of CU TR 021/2011. It is im- to the procedures established by the national portant to note that processing aids are not listed legislation of the Customs Union member state. in the definition of “food products” under CU TR Therefore each member state can have differing 021/2011 and therefore it is unclear as to whether control procedures related to their specific laws all of the rules established for food products are and regulations. applicable to food processing aids (except for state registration as mentioned in the next item).  The Customs Union technical regulations do not provide for a review of food additives based on  According to Decision No. 880 of the Customs new information and data. As such it is unclear Union Commission, the following substances under what process food additives will be re- (food additives, complex food additives, flavor- viewed and possibly removed from the approved ings, plant extracts as flavoring substances and substances in the future. raw materials, starter cultures of microorganisms and bacterial starter cultures, processing aids, Contrary to the Customs Union approach, the European including enzymes) are subject to state registra- Union law focuses not on registration of already ap- tion according to the rules applied to specialized food40. This requires that the applicant (manufac- proved food additives, but rather on assessing safety of ture or importer) submits an application along food additives before they are added to the all-Union list with documentation of test results performed by of approved food additives, as well as on re-evaluation. a laboratory accredited within the Customs Union as well as other evidence that that substance is The European Union establishes that in order to protect safe and that the substance must be in the rel- human health, the safety of additives, enzymes and fla- evant list of approved substances, and must meet vorings for use in foodstuffs for human consumption 39 Article 4, CU TR 021/2011: “food products – products of animal, plant, microbiological, mineral, artificial, or biotechnological origin, that are natural, processed or reprocessed and are intended for human consumption, including specialized food products, packaged potable water, potable mineral water, alcoholic products (including beer and beer-based drinks), non-alcoholic beverages, biologically active ad- ditives (BAA), chewing gum, ferments and starter cultures of microorganisms, yeast, food additives and flavorings, as well as food raw material”. 40 Clause 3.5(4), Decision of the Commission of the Customs Union “On Adoption of Technical Regulation of the Customs Union “On Food Safety” No. 880 of December 9, 2011. As mentioned, all the listed substances shall pass the state registration procedure according to articles 24-26 of CU TR 021/2011. 41 Scheme 1D: For serial production, with carrying out the production control and testing of samples by the manufacturer in a testing labora- tory or in an accredited testing laboratory. Scheme 2D For a products lot, with testing in the laboratory at the choice of the applicant (in in a testing laboratory or in an accredited testing laboratory), Scheme 3D For serial production, with carrying out the production control by the manufacturer and with testing in an accredited testing laboratory. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 70 and the Customs Union of Russia, Belarus, and Kazakhstan must be assessed before they are placed on the  As long as a food additive, flavoring or food en- Community market. Only authorized food additives, zyme is authorized, it can be used by food man- flavorings and food enzymes can be used for produc- ufactures according to the established conditions of use without further approvals. tion of foodstuffs or food additives. Authorization means that a substance is in the List of Approved Food addi-  If an emergency is connected with one of tives. Within the context of the European Union regula- the substances on the authorized lists, the Commission shall take emergency actions ac- tory norms the term “assessment” means the use of risk cording to Regulation (EC) No 178/2002. based process to determine the safety of these materials.  EFSA shall ensure the transparency of its activi- ties by making public its opinions and any exten- There are several key points about the authorization of sions of periods for the provision of additional food additives in the European Union that should be information. Along with transparency, provisions highlighted: of relevant regulations provide for confidentiality.  Regulation (EC) No.1331/2008 lays down a com- The manufacturer of a substance shall indicate mon procedure for the assessment and com- which information he deems confidential when mon authorization of food additives, enzymes the application is submitted. The Commission and food flavorings. Since many food additives, shall then determine which information in the flavorings and enzymes had already been ap- application for authorization is confidential and proved before 2008, authorization covers both shall notify the applicant accordingly. After being new substances, and re-approval of already ap- made aware of the Commission’s opinion on the proved substances. Importantly, the re-approval confidential aspects, the applicant may withdraw is in progress and will be completed by 2020. It its application so as to preserve the confidentiality is anticipated that by 2020 all substances, first of if it does not agree with that opinion. all food additives, will be re-evaluated for safety in the light of new scientific data. There are significant differences between the approval  The common authorization procedure, or the and registration processes between the Customs Union procedure of updating the Community lists of and the European Union. Key differences include: approved substances generally includes the ini-  In the Customs Union no procedures have been tiation of the process, risk assessment by the established for updating Lists of authorized food European Food Safety Authority (EFSA), adoption additives and other similar substances. The Lists of decision and finally updating the lists by the exist as a result of a process beyond the effec- European Commission. tive technical regulations which means that there  Regulations (EC) No 1332/2008 (food enzymes), is no process for manufacturers of new food (EC) No 1333/2008 (food additives) and (EC) No additives to add additional substances to the 1334/2008 (flavorings) establish specific criteria Customs Union market. The European Union has according to which the substances are assessed a well elaborated procedure for authorization of for authorization. The part of authorization pro- new additives and other substances and adding cess is also to determine conditions of use, in them to the authorization lists. This procedure is particular, for what food or food category a sub- lengthy, takes months if not years, and involves a stance can be used, and in what amount. thorough safety assessment by EFSA.  The common procedure lays down the arrange-  In the Customs Union there is no delineated pro- ments for drawing up and updating the EU lists for cedure for removing a substance from the List each category of substances. Only substances includ- of approved substances in view of a new safety ed in these lists are authorized on the Community data. Whereas European Union has a procedure market. Therefore, when a new substance is autho- removing substances from the authorization lists. rized, it means that relevant list will be updated.  The Customs Union requires that all manu-  The regulations establish that all authorized sub- facturers and their representatives who wish to stances are included into relevant Community sell approved food additives or substances in lists. They are assigned a number (in the format of the Union, must submit each substance for the three or four figures), prefixed by letter “E” which conformity assessment procedure (in the form indicates that the substance is authorized. When of declaration of conformity). In the European an authorization is revoked, the substance may Union once a food additive or other substance keep its number, but loses its “E” when/if referred has been approved for use, it can be manufac- to in European Union official documents. tured by any company as long as it complies with specifications. Food and Food-related Articles and Materials that Require Special Authorization 71  During the procedure of state registration in the use, including specific foods they are allowed for and Customs Union only already established autho- the levels of use. rized substances are evaluated against the exist- ing requirements. There is no similar procedure Within the Customs Union conditions of use of food ad- in the EU. However, during the EU authorization ditives and flavorings are established in separate annex- procedure, a new substance goes through an in- es to CU TR 029/2012 under the titles “hygiene norms”. depth risk assessment, and new requirements for its use are elaborated. They are detailed and specific to each of the hundreds of substances and need to be consulted in each case. For companies exporting to the Customs Union and/ or the European Union an understanding which food The European Union also establishes conditions of use additives and substances used, in what format and in and maximum limits for food additives and other similar what amount is critical to ensuring compliance of the substances; they can be found in respective Regulations respective products. Each Union has determined which (1332/2008, 1333/2008, 134/2008), and databases are products are approved, how the various products can available online43. The databases contain thousands be used and at what levels. Both Unions have extensive of records and while they are relatively simple to use, lists that contain over 500 different substances. While again we recommend that prior to manufacturing and the lists of both Unions are positive (include only ap- exporting food additives, flavorings, and processing aids proved substances), they are organized differently. In and/or products that contain these, companies should the Customs Union the list is organized by sequential conduct an in-depth analysis to determine the specific number in the ascending order (from E100 to E1521), requirements. and for each additive its functional classes are listed. The European Union has organized its respective list by As mentioned above, there are differences between the functional classes (26 classes) on the basis of the prin- EU and the CU approval lists. Appendixes 1 is a sum- cipal technological function of the food additive42. It is mary of food additives and substances that are ap- important to note that allocation of a substance to one proved for use in the Customs Union but not in the functional class shall not preclude it from being used for European Union of which there are 43. Appendix 2 is other functions. a summary of those food additives that are approved in the European Union and not in the Customs Union of It is also important to emphasize that when working which there 19. A caution to the reader: these lists are with the lists of authorized substances, attention needs not static and subject to change as the European Union to be paid not only to the identification numbers and continues it process of re-evaluation and approval of names of the substances, but also to their conditions of new Food Additives and substances. 42 Food enzymes: the list is based on Regulation (EC) 1332/2008 (Annex II) and Commission Implementing Regulation (EU) No 1129/2011; food additives: the list is based on Regulation (EC) 1333/2008 (Annex II)) and Commission Regulation (EU) No 1130/201; flavorings: the list is based on Regulation (EC) 1334/2008 and Commission Implementing Regulation 872/2012. 43 Database on food additives is available at: https://webgate.ec.europa.eu/sanco_foods/main/?sector=FAD&auth=SANCAS. Database on food flavorings is available at https://webgate.ec.europa.eu/sanco_foods/main/?sector=FFL&auth=SANCAS . Comparative Analysis of Certain Requirements of Food Legislation in the European Union 72 and the Customs Union of Russia, Belarus, and Kazakhstan Materials and Articles in Contact with Food Materials and articles in contacts with food are all materi- are especially important for companies which intend to als and articles intended to come into contact with food, export to the European Union in that for example, rub- such as packaging and containers, kitchen equipment, ber as a food contact material is listed in the European cutlery and dishes, parts of food processing equipment. Union but is not covered by Customs Union except for These can be made from a variety of materials including some hygienic criteria. plastic, rubber, paper, metal, etc. Safety of food contact materials must be evaluated as chemicals can migrate As the scope of the Customs Union laws and regula- from the materials into food. The safety of food contact tions for food contact materials is limited to packaging materials is regulated in the European Union as well as and closures, the direct comparative analysis between in the Customs Union through a number of legal acts. the Customs Union and European Union will be limited to these subject areas. While both Unions regulate food contact materials there are significant differences between the legal scopes. Key areas of comparative analysis include the scope and Currently within the Customs Union only packaging specific requirements, labeling, authorization, and man- and closure are regulated as materials and articles in ufacturing, safeguard measures, and specific measures contact with food (Customs Union technical regulation (technical requirements). CU TR 005/2011)44,45. In the Customs Union a technical regulation on safety of food contact materials has been drafted but at the time of writing of this report it had not been finalized and put out for public discussion. In the Scope and Specific Requirements European Union the scope of Regulation (EC) 1934/2004 (on materials and articles in contact with food)46 is much There are significant differences between the scope of broader and includes a range of contact materials in- the Customs Union technical regulation 005/2011 and tended to come into direct or indirect contact with food. the European Union legal acts on various food contact Specifically, the scope includes: packaging materials, materials and articles. cutlery and dishes, processing machines, (e.g., conveyor belts), containers used in transport, materials and articles Legal Framework. The European legal framework for in contact with water for human consumption such as food contact materials and articles presents a very dif- bottles, and materials that are used to manufacture ar- ferent approach to that of the Customs Union. Within ticles that are expected to come into contact with food the European Union the regulatory framework for food or transfer their components to foods (normal and fore- contact materials and articles is based on a hierarchy of seeable use). The breadth of the European legislation is laws that builds upon a basic regulation47, that is then significant and only overlaps with the Customs Union in further elaborated in additional legal acts to include a the area of packaging and closures. These differences systematic risk based approach to manufacture of food 44 Technical regulation of the Customs Union 005/2011 “On Safety of Packaging” (it should be noted here that the scope of this technical regulation covers packaging and closure both for foodstuffs and non-food products); Uniform Sanitary and Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Supervision (Control). Chapter II, Section 16. Regulations on Materials and Articles of Polymer and Other Materials Intended to Come into Contact with Food Products and Mediums. 45 The Uniform Sanitary and Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Supervision (Control) have a slightly different approach to determining the range of food contact materials it covers. These materials are listed by codes of Commodity Nomenclature of Foreign Economic Activity (CNFEA) of the Customs Union; these codes are based on two criteria: type of material, and type of equipment. In most cases the codes specify the type of material used to make articles, and then within the category, are divided by specific articles (names of equipment, utensils, etc.,). 46 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. 47 Regulation (EC) 1935/2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. Food and Food-related Articles and Materials that Require Special Authorization 73 contact materials48, to specific laws as necessary for and European Union to a similarity. The European Union various classes and types of materials49. This provides wording does provide flexibility to adapt as new data be- the European Union with a framework that is broad and comes available and new materials due to the generality adaptable to the rapidly changing technology from new of the term. Further the European Union member states biodegradable packing and new chemical additives de- are free to decide about specific implementation of this signed to increase shelf-life, to the incorporation of sen- requirement. sors that can indicate the safety of the product. Safety. Safety is the common requirement in both The Customs Union approach of conformity assessment Unions. In the Customs Union safety has a broader in- in which a packaging or closure material is deemed safe terpretation comparing to the European Union. In the by meeting specific criteria based on testing is effective, Customs Union safety includes limits on the harmful but requires that detailed specifications be determined migration of chemicals into food as well as physical prior to introduction in the market place. This means (general) safety and reliability (e.g., not causing cuts or that the CU legal framework mostly comprises technical scratches on hands, stable to breakage, not exploding)50. specifications for already existing and approved packag- In the European Union migration of chemicals is in- ing and closure. cluded but no EU food safety regulations include physi- cal safety of articles as these aspects of general safety Chemical Migration. With respect to migration of are covered by the European General Product Safety chemicals, the European Union requirements state that Directive No 2001/9551. there shall be no migration causing danger to health and the migration of chemicals shall not cause a change in In the Customs Union packaging requirements (includ- composition and organoleptic properties of the food- ing food packaging) establish additional norms other stuff in contact. In the Customs Union, the requirements than safety – they are related to storage, transporta- establish that there must be no harmful migration as tion and recycling of packaging and closure materials. well and migration limits are set for particular materi- Except for recycling, there are no corresponding re- als. Neither the Customs Union Technical Regulation quirements established in the European Union law. On 005/2011 nor the Unified Sanitary Requirements specify the other hand, in the EU a separate body of require- whether composition and organoleptics are taken into ments is focused on good manufacturing practices for account by the specific hygiene criteria and migration materials and articles in contact with food52. limits. However, based on past experience it can be in- ferred that the Customs Union hygiene criteria do take Recycling. With respect to recycling, EU Regulation into account the need to ensure no change in composi- 1935/2004 favors recycling but does not set specific re- tion and organoleptics. quirements. Recycling of packaging as a type of food contact materials is addressed in Packaging Waste CU TR 005/2011 sets specific hygiene criteria and migra- Directive 94/62/EEC53, and specific requirements to tions limits and prescribes how the testing in model me- recycled cellulose film and recycled plastic are set by dia shall be conducted. The European Union does not separate directives. In the Customs Union, no specific establish such particulars, instead the European Union requirements are set on the recycling processes, and rules establish that harmful migration happens “under they are governed by national laws of member states. no condition”. Such wording brings the Customs Union 48 Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food. 49 Plastics (Regulation EU/10/2011); ceramics (Directive 84/500/EEC); regenerated cellulose film (Directive 2007/42/EC); recycled plastics (Regulation (EC) 282/2008); active and intelligent materials (Regulation (EC) 450/2009), vinyl chloride monomer (Regulation EU/10/2011); release of nitrosamines (Directive 93/11/EEC); certain epoxy derivatives (Regulation1895/2005/EC) 50 Annex I to the CU TR 005/2011. 51 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety. 52 Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food. Manufacturers must establish a quality assurance system (taking account the personnel required to put the system in place and the size of the business) and a quality control system following the detailed manufacturing regulations, for example the processes involving printing inks. 53 European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 74 and the Customs Union of Russia, Belarus, and Kazakhstan Active Materials and Intelligent Packaging. The require- Identification. It is mandatory in the Customs Union to ments of European Union take into account the specif- identify the packaging by number and abbreviation of ics of active materials and intelligent packaging54. This the material it is made of. In the European Union such is not covered by the Customs Union CU TR 005/2011. identification is voluntary. Consumer Information. The Customs Union rules es- tablish that the labeling of packaging and closures shall Labeling of Food Contact Materials and Articles also contain “information for consumers”, without speci- fying what information is required or the form of such Overall, while there are certain similarities, there also information. Comparing this requirement with wordings are many major and minor differences between the in other articles of CU TR 005/2011 it can be inferred that European Union and the Customs Union requirements such information shall be placed on the packaging if it to labeling of food contact materials and articles, includ- cannot be recycled. There are no similar requirements ing packaging and closures. Below is a discussion of key for consumer information on packaging in the legal acts differences between the Unions. of European Union. Indication of Material being Food Grade. The means Recycling labeling. In the European Union while efforts of indicating that a material/article is food-grade in the are made on reducing packaging waste and facilitating European Union includes the use of words, instructions recycling of packaging materials, recycling is voluntary and the glass-and-fork symbol. In the Customs Union as is the respective labeling. In the Customs Union, TR requirements, only the symbol shall be used. Also, in the 005/2011 establishes that the labeling of packaging and Customs Union a crossed glass-and-fork symbol is used closures shall contain (among other particulars), infor- for packaging that is not intended for food contact (no mation on possibility of recycling in the form of Mobius detailed rules have been established)55. Loop. The wording of this requirement is vague and leaves room for interpretation. It is unclear whether all Traceability. The European Union rules clearly require packaging and closures shall be marked (with Mobius that labeling contains information for the purposes of Loop for recyclable items, and in an unclear way for traceability. In the Customs Union the labeling requires non-recyclable items), or whether it is assumed that all particular information be placed on the label (e.g., man- of the packaging is recyclable, or whether, if the pack- ufacturer and date of manufacturing). This does allow a aging is recyclable, then it shall be marked with Mobius degree of traceability that in some cases, depending on Loop. Based on experience and evaluation of numerous the record-keeping system of the food business opera- Customs Union approved labels it can be inferred that tor, may be similar to the level of traceability required in most likely the intention is to label articles when all of the the European Union. packaging is recyclable. The Customs Union Technical 54 Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into con- tact with food. “Active food contact materials and articles” means materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food. They are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food (definition from Article 2.2(a) of Regulation (EC) No. 1935/2004). See more information, for example, in EU Guidance to the Commission Regulation (EC) No 450/2009, DG SANCO, 23 November 2011, available at: http://ec.europa.eu/food/food/chemicalsafety/foodcontact/docs/guidance_active_and_intelligent_scof- cah_231111_en.pdf; Active and Intelligent Packaging: Innovations for the Future, K. Huff, Department of Food Science and Technology, Virginia Polytechnic Institute and State Univ. Blacksburg, Va. Active packaging systems are developed with the goal of extending shelf life for foods and increasing the period of time that the food is high quality. Active packaging technologies include some physical, chemical, or biological action which changes interactions between a package, product, and/or headspace of the package in order to get a desired outcome. The most common active systems scavenge oxygen from the package or the product and may even be activated by an outside source such as UV light. Active packaging is typically found in two types of systems; sachets and pads which are placed inside of packages and active ingredients that are incorporated directly into packaging materials. Intelligent materials and articles means materials and articles which monitor the condition of packaged food or the environment surrounding the food packaging with a time-temperature indicator is an example of an intelligent packaging. Time-temperature indicators are meant to give information on whether a threshold temperature has been exceeded over time and/or to estimate the minimum amount of time a product has spent above the threshold temperature (time temperature history) e.g. from the moment the food it is packed until consumption. The indication is often a visual signal. A positive visual signal could indicate that a product is not fresh anymore or not suitable to be eaten. 55 Article 6 of CU TR 005/2011. Food and Food-related Articles and Materials that Require Special Authorization 75 Regulation does not elaborate on the responsible party Authorization for placing the mark on the packaging including in the case of imported packaging and closure. Further it is In the European Union and the Customs Union authori- unclear how and if at all the use of the Mobius Loop zation procedures exist for materials and articles intend- complies with generally accepted international prac- ed to come into contact with food, including packaging tice and globally recognized standards. Internationally and closures. They differ in process based on the re- Mobius Loop is used based on the ISO 14021:1999 spective Union’s fundamental approach to food safety “Environmental labels and declarations – Self-declared control. environmental claims (Type II environmental labeling)”, and placing the symbol on an item is voluntary even if In the Customs Union, for each packaging/closure in- the item is recyclable indeed; also, to place the Mobius troduced by a manufacturer, whether the specific pack- Loop on a package, beyond the recyclability, other con- aging or closure is new or not, he must complete the ditions shall be observed, including there must be ac- assessment of conformity process within the require- cessible facilities to recycle the item. According to CU TR ments of TR TU 005/2011 and other relevant technical 005/2011, Mobius Loop symbol is mandatory, and there regulations of the Customs Union. The assessment of are no additional conditions, other than recyclability of conformity is done through execution of declaration of an item. conformity by a manufacturer (or an authorized repre- sentative, or an importer) based on tests results from an Labeling of Active Packaging Materials. The European accredited laboratory. Union has established a set of rules that require addi- tional specific information to be placed on the label of In the European Union, authorization procedures apply “active materials”. For example, when a product contains to new substances, materials, and articles made of new a sachet, the sachet must be labeled as non-edible with substances and/or materials not yet listed in regulations, the statement “do not eat” to avoid consumer consump- and the procedure shall be made once before the sub- tion of the material; elements of an intelligent packaging stance is first put into manufacture. The process is based whenever they are perceived as edible shall be labeled on a thorough risk assessment done by EFSA56 to deter- in a similar manner. When technically practical, a special mine that the substances, materials, and articles made of symbol should be added as well. Within the Customs new substances and/or materials have sufficiently dem- Union there are no specific requirements for labeling of onstrated that they do not present risks to human health. “active materials/intelligent packaging”. In some member states, additional requirements may apply for individual business operators57. At the same time, in the European Union for selected groups of food contact materials and articles it is required to develop a declaration of compliance58. 56 EFSA Note for guidance for petitioners presenting an application for the safety assessment of a substance to be used in food contact ma- terials prior to its authorization (based on Guidelines of the Scientific Committee on Food for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorization. SCF/CS/PLEN/GEN/100 Final of 19 December 2001). 57 SANCO E6/KS (26/09/2013). Summary of the National Legislation on Food Contact Materials. 58 For several groups of materials and articles intended to come into contact with food, as a specific measure it is required to accompany them with a declaration of compliance. A written declaration shall state that such materials and articles comply with the specific rules ap- plicable to them. Declaration of compliance shall accompany the following materials and articles in contact with food: Plastics, Recycled plastics, Ceramics, Active and Intelligent materials. Appropriate documentation shall be available to demonstrate the compliance. The documentation shall be made available to the competent authorities on demand. In the absence of specific measures, member states can adopt national provisions to require declarations of compliance. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 76 and the Customs Union of Russia, Belarus, and Kazakhstan Manufacturing and range from the criteria of purity and specific condi- tions of use to limits on migration, collection of samples, In the European Union it is required that manufacturers of traceability and establishing the list of substances autho- food contact materials and articles implement good man- rized for use in the manufacture of materials and articles ufacturing practices based on quality assurance programs that are intended to come into contact with food61. In and quality control procedures59. In the Customs Union the European Union these are only developed for se- the manufacturing requirements are limited to the process lected materials and articles62. control for serial manufacturing of packaging/closures. This requirement, combined with the detailed quality control In the Customs Union, specific measures basically cover methods established by GOST standards referred to in the only the issue of migration from packaging/closure in Customs Union TR 005/201160 may ensure a similar level contact with food, but are developed for all materials of control as the European Union requirements with a ma- used in manufacture of packaging within the scope of jor exception in that the Customs Union requirements on CU TR 005/2011. process control only refers to the process of manufacture of packaging/closure, but not of substances thereof, or other A special case remains active materials and intelligent processes (steps) like transportation, distribution, etc. Also packaging which is regulated in the European Union specifically “Active” packaging materials are not covered in through special measures, but not regulated in the the Customs Union technical regulations or GOST standards. Customs Union. It is advisable for companies wishing to export to the Customs Union and/or the European Union also to con- Safeguard Measures sult national legislation referred to in the Customs Union TR 005/2011 and the referenced GOST standards. The Customs Union and European Union have safeguard measures that foresee suspension, restriction, or ban for food Also, since the rules applicable to food contact mate- contact materials and articles (European Union) or packag- rials and articles are very technical, for further reading ing/closure (Customs Union) under certain conditions. Such on the European Union legislation it is recommended conditions however, are different for the European Union to study individual regulations and directives, and guid- and the Customs Union. In the European Union safeguard ance documents on their application. A good example measures apply for the approved food contact materials and of such freely available guidance document is a pub- articles when it becomes known that for any reasons they lication by United Kingdom’s Food Standards Agency: present a danger to human health. In the Customs Union “Explanatory Note: Legislation Controlling Materials safeguard measures apply if packaging/closure does not and Articles Intended to Be Brought into Contact With comply with technical regulations which includes non- Food”, July 200963. As for the Customs Union, Belarusian compliance being related to food safety issues and/or other State Institute of Metrology (BelGIM) developed issues not related to endangering human health. Methodological Recommendations on Application of Technical Regulation of the Customs Union CU TR 005/2011 “On Safety of Packaging”. At the time of writing an official copy of the document was not freely down- Specific Measures loadable from the Belarusian website; and was offered for purchase from the Institute64. The specific measures in the European Union on ma- terials and articles in contact with food are quite broad 59 Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food. 60 Approved by Decision of the Customs Union Commission No. 769 of August 16, 2011. 61 A complete list of the requirements are found in the EU Framework Regulation (EC) 1935/2004. 62 Materials and articles include: ceramics; regenerated cellulose; plastics; recycled plastics; active and intelligent materials and articles, Nitrosamines and Certain epoxy derivatives 63 http://multimedia.food.gov.uk/multimedia/pdfs/foodcontguide010709.pdf 64 http://www.belgim.by/uploaded/pdf/MR%20upakovka.pdf Food and Food-related Articles and Materials that Require Special Authorization 77 Considerations it is not made public and/or cannot be accessed This report covers a range of materials and food related by the public in any format. commodities – novel food, dietary supplements, food  Scope of the requirements. In general, the additives and other substances for technological pur- scopes of requirements on various commodi- poses, food contact items and materials - each with its ties analyzed in this report differ between the own regulations, regulatory environment, and specifics. European Union and Customs Union. Sometimes For all these materials, substances, articles special au- the differences are minor; in other cases they are thorization/registration procedures apply. In each case major. For example a major difference, is the very there are similarities and differences in how specific low correspondence between requirements on dietary supplements, which are understood as vi- issues are addressed in the European Union and the tamins and minerals in the European Union, and Customs Union. biologically active supplements in the Customs Union for which vitamins and minerals are only a small part of substances covered. Other examples refer to; GMO excluded from novel food regula- Cross-Cutting Differences tion in the European Union but covered by novel  Transparency. The norms and rules established food rules in the Customs Union, food contact in the European Union provide more clarity materials and articles in the European Union and transparency with respect to those of the versus packaging and closures in the Customs Customs Union. This refers to authorization pro- Union. cedures and reasoning for specific requirements.  Length of the procedures. State registration and While in most cases it might not be important for conformity assessment procedures used in the food business operators, sometimes, when there Customs Union are much faster than authori- are significant differences in particular require- zation procedures in the European Union. This ments, transparency can help to better under- may seem favorable for food business. But, at the stand the intent and specificity of the regulations. same time, conformity assessment procedures  Detailed intents. Legal acts in European Union apply to all food manufacturers, irrespective of clearly define not only the purpose of adoption, whether the food they produce is already au- but also an intent (or intents) of the legal acts. thorized or not. In the European Union authori- Detailed intents are not specified in the Customs zation procedures are quite lengthy, but as long Union regulations. Detailing intents helps sig- as an authorization is granted, no further specific nificantly in understanding the essence of legal approvals are needed for individual food business requirements and also to anticipate and comply operators. with possible future changes in the requirements.  Steps and nuances of the procedures. With re-  Flexibility. The European Union requirements gard to all groups of requirements analyzed dif- are significantly more flexible than the norms in ferences were identified on specific aspects of the Customs Union. It does not mean that they authorization procedures: availability of infor- are loose. Instead flexibility means that they are mation, the network of bodies responsible for more adaptable to changes and innovations that approvals and authorizations, time limits, dis- may happen in the food industry, as well as to semination of data, and suspension procedures. new scientific data that may reveal possible food  Objects of the authorization (registration) pro- safety issues related, for example, to the approved cedures. In most cases, in the European Union substances or safety criteria. authorization procedures are established for  Risk assessment. In the European Union autho- commodity when the commodity is first put into rization procedures for novel food, food supple- circulation. In the Customs Union, authorization ments, food additives, flavorings, food contact or registration procedures apply to commodities materials and articles are all based on risk assess- that are first put into circulation by each individ- ment. This gives scientific soundness to authori- ual manufacturer (importer), if such commodities zation decisions, as well as to new norms, food subject to state registration. safety criteria, etc. In the Customs Union, deci-  Number of legal acts. There are relatively few le- sions are taken on a scientific basis as well but the gal documents in the Customs Union. In contrast, specific basis is unclear and remains unknown as the European Union has numerous regulations, Comparative Analysis of Certain Requirements of Food Legislation in the European Union 78 and the Customs Union of Russia, Belarus, and Kazakhstan directives, and guidance documents covering  Identify the legal acts applicable to your specific these commodities. Consequently, while the le- product; gal acts of the Customs Union are relatively few  Check whether the specific product falls under in number the content is specific and in such the scope of regulations in the target trading detail that it makes the documents cumbersome Union; to use. Alternatively, within the European Union  Check if authorization is required and if yes, what legal acts are more structured but as the number are the specific rules, anticipated duration of the of documents is significantly larger there is the procedure, and expected costs; potential to overlook or miss critical documents.  For those who target the market of the Customs For governments in third countries some of the prac- Union – check which forms of conformity as- tices used in the European Union and the Customs sessment are applicable to your product, and what specific related provisions of conformity as- Union can serve as good examples, in particular, flex- sessment apply; ibility and transparency of European norms and the set-  For those who plan to use items that require au- ting up strict time limits for some official procedures in thorizations – check if the item you plan to use the Customs Union. Also, some specific highly technical is authorized at the target market (for example, norms, for example lists of approved food additives can check if a food additive is authorized); check be used as benchmarks for countries who do not wish whether the authorizations are accompanied to undertake the time and expense to achieve the level with specific conditions of use (for example, for of scientific research and risk assessment as is available food additives – maximum limits, restrictions to in the European Union. use in certain products);  Finally, these areas are rather complex and de- For food businesses considering export to one of the tailed and we recommend that guidance docu- markets, it is recommended to pay additional attention ments and training be specifically developed for to the following: the government and industry. Food and Food-related Articles and Materials that Require Special Authorization 79 List of Food Additives Authorized in the Customs Union but NOT Authorized in European Annex 1 Union № E-number Name of food additive № E-number Name of food additive 1 E143 Fast green FCF 23 E381 Ferric ammonium citrate 2 E181 Tannins, food grade 24 E384 Isopropyl citrates mixture 3 E201 Sodium sorbate 25 E386 Disodium EDTA 4 E225 Potassium sulfite 26 E387 Oxystearin 5 E231 Orto-phenylphenol 27 E510 Ammonium chloride 6 E232 Sodium O- phenylphenol 28 E518 Magnesium sulphate 7 E236 Formic Acid 29 E539 Sodium thiosulphate 8 E265 Dehydroacetic acid 30 E542 Bone phosphate 9 E266 Sodium dehydroacetic acid 31 E580 Magnesium gluconate 10 E303 Potassium ascorbate 32 E636 Maltol 11 E314 Guaiac resin 33 E637 Ethyl maltol 12 E409 Arabinogalactan 34 E905d Mineral oil (high viscosity) 13 E430 Polyoxyethylene (8) stearate Mineral oil (medium and low 35 E905e 14 E467 Ethyl hydroxyethyl cellulose viscosity) 15 E480 Dioctyl sodium sulpho-succinate 36 E907 Hydrogenated poly-1-decene 16 E484 Stearyl citrate emulsifier 37 E928 Benzoyl peroxide 17 E264 Ammonium acetate Dextrins, roosted starch white and 38 E1400 yellow 18 E328 Ammonium lactate 39 E1401 Acid treated starch 19 E329 Magnesium lactate, dl 40 E1402 Alkaline treated starch 20 E342 Ammonium phosphates 41 E1403 Bleached starch 21 E359 Ammonium adipates 42 E1405 Starches enzyme-treated 22 E365 Sodium fumarates 43 E1503 Castor oil List of Food Additives Authorized in European Union but NOT Authorized in the Customs Annex 2 Union № E-number Name of the food additive № E-number Name of the food additive 1 E123 Amaranth 12 E969 Advantame 2 E127 Erythrosine Octenyl succinic acid modified gum 13 E423 3 E154 Brown FK Arabic 4 E173 Aluminum 14 E499 Stigmasterol-rich plant sterols 5 E180 Litholrubine BK 15 E512 Stannous chloride 6 E239 Hexamethylene tetramine 16 E1205 Basic methacrylate copolymer 7 E243 Ethyl lauryl arginate 17 E1206 Neutral methacrylate copolymer 8 E284 Boric acid 18 E1207 Anionic methacrylate copolymer 9 E285 Sodium tetraborate; borax 10 E1105 Lysozyme Polyvinylpyrrolidone-vinyl acetate 19 E1208 copolymer 11 E964 Polyglycitol syrup Comparative Analysis of Certain Requirements of Food Legislation in the European Union 80 and the Customs Union of Russia, Belarus, and Kazakhstan Laboratory Control and Food Safety Criteria in the European Union and the Customs Union acts; the comparison is done through testing of the fi- nal products attributes including food safety parameters. Therefore, in the Customs Union, the key to ensuring safe food is to conform/verify that the final product con- forms in all aspects with the technical regulations and/ or specific standards. In the European Union the food Executive Summary safety control is at its core a risk-based process in which hazards are identified and controlled at all levels in the The ability to provide safe and nutritious food domesti- food chain from farm-to-fork through preventive meth- cally and for export is a shared responsibility of industry ods rather than testing of final products. The differences and governments. In order to deliver on this commit- in these two approaches lead to significant differences ment, governments and industry must have the ability in establishment of hazards, setting of acceptable limits to identify and control food safety hazards. Food safety for chemicals, pesticides, pathogenic microorganisms, hazards are biological, chemical or physical agents that veterinary medicines residues, authorization of products can be found in food or in contact with food that have and substances, testing, sampling and the role of labo- the potential to cause an adverse health effect. These ratories within the respective systems. hazards are found throughout the food supply chain and are a significant public health concern. To ensure The comparative analysis of the Customs Union and that food is safe, governments have established specific European Union requirements on acceptable limits for rules and acceptable levels of presence of hazards in pathogens, pesticides, veterinary drugs, chemicals as food and in this way differentiate safe food from unsafe well as sampling, testing and laboratories is a highly food. All food that is placed on the market must com- complex scientific and technical set of topic areas. To ply with the safety levels of hazards presence in food, help to better understand this legal analysis we have and in some cases, for especially dangerous substances, included into this document some basic information zero acceptable levels are established. The safety levels about hazards, as well as examples of specific com- are not arbitrary: they are based on substantial scientific parisons for illustrative purposes. Considering that the research, and as new scientific information becomes Customs Union microbiological criteria, acceptable lim- available, safety levels for food hazards are revised. To its for contaminants, pesticides and veterinary drugs are effectively assess presence of hazards in food, it is im- very detailed and organized in a rather complex man- portant to have adequate laboratory capacity, to use ner in the technical regulations, and are not easy to statistically sound sampling techniques, and reliable, ac- be immediately grasped by people unfamiliar with the curate and repeatable analytical test methods. Customs Union system, summary overview tables have been prepared and are available as part of the expanded The Customs Union and the European Union have a version of the report. Since specific parameters are set long history of controlling hazards in food to ensure for food categories, and in the Customs Union and the the safety of the food that consumers eat and drink. European Union food categories are organized based Both Unions have established systematic approaches on different principles and criteria, it is not practical to in which hazards are determined; allowable limits are prepare a category-by-category (or product-by-product) established; and schemes for sampling, testing and re- comparison for microbiological criteria and contami- porting the results have been instituted. The approach nants. In view of the complexity of the topic areas we to food safety control differs between the two Unions. must point out that for businesses wishing to export to The Customs Union food safety control system to a either EU or CU it is key to conduct an in-depth spe- significant extent is based on conformity assessment in cific analysis of legal provisions relevant to products they which food products are deemed safe based on a com- wish to export as each foodstuff and class of foodstuffs parison with product specifications as outlined in legal has specific requirements that must be met. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 82 and the Customs Union of Russia, Belarus, and Kazakhstan Microbiological Criteria for Foodstuffs – Approaches and a Comparison of Parameters Microbiological hazards (bacteria, viruses, fungi, proto- 3. Presence of some microorganisms that are zoa, parasites, yeasts) in foodstuffs are a major source pathogens clearly says that the food is unsafe of food-borne diseases in humans. Foodstuffs of ani- (e.g., contamination with Salmonella). Presence mal and plant origin may present a significant threat of other microorganism as indicated by the mea- to health first of all due to microbiological contamina- surement of Total Plate Count2 does not neces- tion; microbiological hazards can be naturally occurring sarily mean that food is unsafe. Instead a high and come into food chain with the raw material, or can Total Plate Count is an indicator that the total mi- contaminate food at any food chain step. Foodstuffs crobial count in the product is high which sug- should not contain microorganisms and their toxins or gests that the conditions of production were not metabolites in quantities that present unacceptable risk hygienic enough to meet the required norms. for human health. Microbiological criteria are tools that High levels of indicator organisms are used as a can be used in assessing the safety and quality of foods. test for hygienic production as well as an indi- Requirements on microbiological criteria are established cation that the product may contain pathogenic in the Customs Union and the European Union in legal microorganisms in concentrations high enough acts that form an important part of the food safety regu- to be of concern. latory framework. 4. Within some bacteria families, some bacteria are more harmful than others. For example, within Within the area of food microbiology there are sever- the class of coliforms (rod-shape bacteria), one of al important aspects that guide the approaches of the the species that includes harmful bacteria strains Customs Union and the European Union to food safety is Escherichia Coli (E.Coli); most of E.Coli strains microbiological control. are harmless, but some serotypes can cause se- rious foodborne infection; the most pathogenic 1. Not all microorganisms are harmful and therefore serotype is E.Coli O157:H7. it is not a purpose of food processors or regula- tors to kill 100% of microflora in food. For exam- 5. Some microorganisms are spoilage microorgan- ple, some bacteria cultures are the basis for the isms – they cause spoilage (which is a tactile, preparation of yogurt and cheese and therefore visual and olfactory or flavor change that is unac- should not and cannot be eliminated from cer- ceptable) but very rarely render food unsafe. For tain foodstuffs. example high levels of certain yeasts and bacte- ria can cause formation of carbon dioxide gas 2. In some instances harmful (pathogenic) micro- in packaging which leads to packaging swelling organisms are harmful to humans in all cases. and exploding at storage. While this is not a direct Other organisms are only harmful under certain food safety risk it is a significant risk to the prod- conditions, for example organisms can rapidly uct stability, durability and product acceptability take advantage of favorable conditions that al- in the market3. low rapid growth and therefore become a hu- man health hazard (conditionally pathogenic or 6. In some cases, infection is caused not by opportunistic pathogens)1. bacteria, but by a toxin that the bacteria pro- duce. For example in humans, respiratory 1 For example, ready-to-eat foods can support the growth of pathogenic (food poisoning) bacteria and must be kept at certain temperatures to minimize the growth of any pathogens that may be present in the food or to prevent the formation of toxins in the food. Examples in- clude, but are not limited to, sandwiches, kebabs, sushi, takeaway foods and bakery products. Ready-to-eat foods usually include a number of ingredients which may or may not be cooked. 2 Total Plate Count is also referred to as Standard Plate Count or Aerobic Plate Count. A similar criterion used in the Customs Union is total number of mesophyll aerobic and facultative anaerobic bacteria. A standard plate count will not differentiate between the natural micro- flora of a food, spoilage microorganisms, organisms added to fermented foods or pathogenic microorganism. It cannot be used to predict the safety of the product and will be influenced by the storage conditions of the product. Depending on the product, a high standard plate count may indicate that the product may have been prepared unhygienically or stored inappropriately. 3 http://www.foodsafetymagazine.com/magazine-archive1/junejuly-2012/flavors-should-burst-not-packages/ Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 83 passages, skin and superficial wounds are com- vertical product-specific technical regulations; in a com- mon sources of Staphylococcus aureus, and bined form they can be found in the Uniform Sanitary, when Staphylococcus aureus is allowed to grow Epidemiology and Hygiene Requirements for Products in foods, it can produce a toxin that causes illness4. Subject to State Control (Supervision)5. At the same time, 7. When a material is sampled the larger the sample it shall be kept in mind that as a general rule, when a size is, the more likely that that microorganisms product-specific technical regulation is adopted, the rel- may be be detected. It is simply a matter of statis- evant section(s) of the Uniform Sanitary, Epidemiology tics: the more samples are taken the more likely and Hygiene Requirements loses its validity for prod- it is to find an organism. Therefore a sample size ucts covered by the scope of the technical regulation. of 5 grams may yield a negative result (no patho- gen found), whereas when a 100 gram sample is Therefore, the Customs Union has a significant body of tested, a positive result may be found. technical regulations that establishes specific types and 8. As food is highly complex material or matrix and quantities of microorganisms that are allowed in food6. is not uniform, the more samples are taken, the The European Union approach is purely horizontal: all more representative the samples are of the total microbiological criteria for all foodstuffs are consoli- amount of product. For example if one is test- dated in one Regulation (EC) No 2073/2005 “On micro- ing production of 1000 kg of meat in a single biological criteria on food”. This Regulation is a part of batch, then the more samples are taken in differ- the EU preventive approach to food safety and is tightly ent places in the 1000 kg, the more representative linked to other food safety tools (first of all HACCP) and the sample is of the total 1000 kg versus a single relevant legal acts7. sample taken at 1 place. Therefore, increasing the number of samples increases the potential to de- Microbiological requirements of the Customs Union tect undesirable microorganisms. are focused on a combination of pathogens as well While the Customs Union and the European Union have as indicative and spoilage microorganisms in finished specific controls for microorganisms in food the ap- products. This is due to the intent and regulatory frame- proaches they use are significantly different. The Customs work of the Customs Union that is based on finished Union has a combination of vertical and horizontal legal product conformity assessment as a mechanism to acts that are used for establishing microbiological require- control food safety and quality as well as food identifi- ments to foodstuffs: they combine general requirements cation. The European Union microbiological criteria are set for all foodstuffs in a horizontal CU TR 021/2011 “On targeted at specific hazards, specifically those micro- Food Safety” with additional requirements established in organisms that are directly associated with foodborne 4 Although cooking destroys the bacteria, the toxin produced is heat stable and may not be destroyed. Staphylococcal food poisoning oc- curs most often in foods that require hand preparation, such as potato salad, ham salad and sandwich spreads. Sometimes these types of foods are left at room temperature for long periods of time, allowing the bacteria to grow and produce toxin. Good personal hygiene while handling foods will help keep S. aureus out of foods, and refrigeration of raw and cooked foods will prevent the growth of these bacteria if any are present. 5 Customs Union Technical Regulation 021/2011 “On Food Safety”; Customs Union Technical Regulation 005/2011 “On Fat and Oil Products”; Customs Union Technical Regulation 023/2011 “On Fruit and Vegetable Juice Products”; Customs Union Technical Regulation 027/2012 “On Safety of Certain Types of Specialized Food Products Including Therapeutic and Preventive Dietary Food”; Customs Union Technical Regulation TR CU 033/2013 “On Safety of Milk and Dairy Products”; Customs Union Technical Regulation TR CU 034/2013 “On Safety of Meat and Meat Products”. Importantly, microbiological criteria are also set by the Uniform Sanitary and Epidemiological and Hygienic Requirements for products subject to sanitary and epidemiological supervision (control), Chapter II, Part 1, “Requirements for safety and nutrition value of food products”. As it is explained in the Explanatory Note to the Technical Regulation CU TR 021/2011, the requirements, including on microbiological safety, are based on national laws of the Customs Union member states and on international requirements. 6 Due to the significant size of each Customs Union technical regulations, it is advisable in each particular case to refer to the applicable clauses and annexes of the relevant legal acts. 7 In addition to Regulation (EU) 2073/2005, microbiological requirements are established on raw milk (in Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin), however they are not food safety requirements. As explained in Regulation (EC) 2073/2005, microbiological criteria have been established based on Codex Alimentarius guideline “Principles for the establishment and application of microbiological criteria for foods, CAC/GL 21- 1997”; in addition to this, existing Codex specifications in respect of dried milk products, foods for infants and children and the histamine criterion for certain fish and fishery products have been taken into account. The criteria are also based on the advice of the Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) and the Scientific Committee on Food (SCF) of the European Commission in laying down microbiological criteria. Also, European Food Safety Authority (EFSA) provides its scientific opinions and support where it comes to scientific assessment and review of various food hazards, including microbiological hazards. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 84 and the Customs Union of Russia, Belarus, and Kazakhstan diseases. Such hazards are controlled through preven- final product controls and testing, the Customs Union tive or control measures under HACCP programs, and technical regulations do not establish microbiological the compliance is verified through official HACCP audits requirements for production processes. In contrast, due by a competent authority. Microbiological tests are used to the European Union’s preventive and risk-based ap- as an instrument of verification of HACCP effectiveness. proach, control of pathogens is required during pro- This focus on specific hazards is a reflection of the in- duction processes as well (legal criteria are established tent and supporting legal framework of the European for specific process steps, usually at the end of the man- Union targeted at prevention of production of unsafe ufacturing process), and safety is verified again when food; other issues related to quality and possible spoil- foodstuffs are at the market. These differences are sum- age are not controlled through enforcement. In ad- marized in Table 1 below. dition, as the Customs Union approach is based on Comparison of Groups of Microorganisms for which Microbiological Criteria are Established in Table 1 the Customs Union and the European Union Customs Union – Groups of European Union – Microorganisms Groups of Microorganisms Criteria for finished products (upon Criteria for products placed on Criteria for production processes conformity assessment before the market (finished products/food (in-process products (usually end of putting into circulation) safety criteria) manufacturing)/process hygiene criteria) Pathogens + + Conditional pathogens - + Indicator + (in one case only, E.coli in live + microorganisms bivalve mollusks and shellfish8) Spoilage microorganisms - - Live cells - - From the human health perspective, the most important of microorganisms for which a comparison is possible, for comparison of the CU and EU microbiological crite- because it is the only common group covered by the ria are pathogens. In fact, pathogens are the only group Customs Union and European Union norms (Table 2). 8 Live bivalve mollusks and live echinoderms, tunicates and gastropods (Clause 1.2.5 of Chapter 1 “Food safety criteria” of Annex 1. “Microbiological criteria for foodstuffs”, Commission Regulation (EC) 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 85 Comparison of Specific Pathogens for which Microbiological Criteria are Established in the Table 2 Customs Union and the European Union Pathogens covered by microbiological criteria Pathogens covered by microbiological criteria according to the Customs Union technical (food safety criteria) according to European Union regulations regulations Pathogenic microorganisms incl. Salmonella Salmonella Salmonella typhimurium, Salmonella enteritidis Listeria monocytogenes Listeria monocytogenes Enterobacter sakazakii Cronobacter spp. (Enterobacter sakazakii) Yersinia Spp. Not covered9 Staphylococcus enterotoxins Staphylococcal enterotoxins Not covered Shiga-toxin producing E. coli10 (STEC) O157, O26, O111, O103, O145 and O104:H4 Not covered11 Histamine Both Unions apply rigorous microbiological controls to European Union control system focuses on pre- ensure food safety. While the objectives of food safety vention of product non-conformities throughout are achieved by both systems, there are systemic and the manufacturing process. Therefore while in specific differences that have an impact on businesses the Customs Union the focus is on final product wishing to export to either or both Unions. For govern- testing, the European Union testing when re- ments, while harmonization with either Union is pos- quired is conducted at all levels of the food sup- sible, it is not practical or reasonable to simultaneously ply chain and includes in-process testing (usually harmonize due to the significant differences in approach at the end of the manufacturing process) and to microbiological control. testing of end-product after it is placed on the market to ensure that the product is safe through The major differences in approach to microbiological its shelf-life. control are summarized below and include:  Requirements of the Customs Union establish  The Customs Union approach of conformity that foodstuffs must comply with general micro- assessment requires greater testing of the final biological criteria established in CU TR 021/2011 food product for a wider range of criteria includ- and additional criteria under the scope of prod- ing those related to quality, spoilage, and food uct-specific technical regulations. Foodstuffs for safety. The European Union’s approach is based which product-specific technical regulations on a risk-based system from farm-to-fork which have not been developed yet or have not entered by design is focused on preventative and control into force, shall comply with general microbio- measures through production process based on logical criteria. Within this context only the micro- HACCP principles and focused on specific food bial tests which are directly specified for a specific safety related microorganisms. product are carried out. Therefore, it is not pos- sible to test a product for a microorganism that  The food safety control in the Customs Union is not listed in the specific product specification focuses on end-product testing before the even if new scientific data indicates that this may product is placed on the market, whereas the be of concern. 9 Yersiniosis as a disease from Yersinia Spp. does not occur frequently. It is rare unless a breakdown occurs in food processing techniques. http://www.fda.gov/Food/FoodborneIllnessContaminants/CausesOfIllnessBadBugBook/ucm070040.htm . 10 A novel strain of Escherichia coli O104:H4 bacteria caused a serious outbreak of foodborne illness focused in northern Germany in May through June 2011; all in all, 3,950 people were affected and 53 died, 51 of whom were in Germany. 11 Histamine is not covered by the Customs Union microbiological requirements (instead, it is covered in other sections of technical regula- tions as a different type of hazard). Comparative Analysis of Certain Requirements of Food Legislation in the European Union 86 and the Customs Union of Russia, Belarus, and Kazakhstan  The European Union microbiological criteria are group their products belong, the European Union not specific to a particular product but instead Commission has developed a special guidance are established across broad product categories. document14. No such grouping is used in the Further special clauses of the Regulation (EC) Customs Union legal acts. 2073/2005 give right to competent authority to  The Customs Union technical regulations do not test for other microorganisms in case of food establish other requirements for food business safety concerns, and oblige food business opera- operators with regard to microbiological criteria tors to identify other relevant microorganisms as in addition to the requirement to comply with significant microbiological food safety hazards specific limits; the European Union regulatory within their HACCP control programs, allowing framework includes many additional require- the European Union to expand the list of micro- ments related to the application of microbiologi- organisms tested as needed12. cal criteria, including the obligations to conduct  While in the Customs Union HACCP is manda- additional studies, take certain actions in case of tory for food manufactures, microbiological re- non-conformities, analyze trends in test results quirements are set for the final products before and improve processes. they are placed on the market, and are not inte-  The Customs Union technical regulations estab- grated into implementation of HACCP programs lish sampling plan requirements for a relatively throughout the food chain to the extent as in the small number of cases; for the remainder, sam- European Union. pling plans are established through GOST stan-  Customs Union technical regulations do not set dards and Methodologies that are referred to requirements on microbial criteria for production by each particular technical regulation. Testing processes, while in the European Union part of methods are established by GOST standards and microbiological criteria are focused on produc- Methodologies. The European Union require- tion processes and process hygiene (they are ments on microbiological criteria are set in close called process hygiene criteria). connection with the sampling plan and reference  Some of the Customs Union microbiological cri- testing method for each criteria in Regulation (EC) teria are established for the purposes of product 2073/2005. identification only (with the aim of conformity  There are differences in technical aspects: assessment, e.g., for fermented dairy product); in  In many cases the Customs Union and the the European Union no such microbiological cri- European Union microbiological criteria re- teria are established. quire different number of samples to be taken;  The food categories for which microbiological  In many cases the European Union micro- criteria are established in the Customs Union biological criteria use units of measure for the and the European Union, while may seem dif- tolerance limits that are not applicable in the ferent and not easy to correlate, in fact cover to Customs Union; the most extent similar food categories. The one  At the level of specific combinations of microor- significant exception is grouping of foods in the ganism/product there are many differences be- European Union by their ability or inability to sup- tween food safety criteria in the Customs Union port the growth of Listeria monocytogenes (LM). and the European Union; This grouping refers to ready-to-eat foods, and as such the two categories (ready-to-eat, able to  Specific tolerance limits of microbiological cri- support the growth of LM, ready-to-eat, not able teria as established by the Customs Union and to support growth of LM13) cover many foods, that the European Union legal acts are similar in some otherwise would not be covered by other food cases, and different in other cases. categories. To help producers to decide to which 12 The competent authority shall verify compliance with the rules and criteria laid down in Regulation (EC) 2073/2005 in accordance with Regulation (EC) No 882/2004, without prejudice to its right to undertake further sampling and analyses for the purpose of detecting and measuring other microorganisms, their toxins or metabolites, either as a verification of processes, for food suspected of being unsafe, or in the context of a risk analysis (Article 1, Regulation (EC) 2073/2005 on microbiological criteria in food). 13 Some examples: ready-to-eat foodstuffs able to support the growth of LM: pre-packed sliced cooked meat, smoked salmon, soft cheese; ready-to-eat foodstuffs not able to support the growth of LM: ice cream, hard cheese, products with shelf life of less than 5 days e.g. sandwiches and some unpackaged delicatessen products if prepared in store. 14 Commission Staff Working Document Guidance Document on Listeria monocytogenes shelf-life studies for ready-to-eat foods, under Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 87 For potential food exporters the differences between products to the European Union market, they should be the Customs Union and the European Union as listed prepared for microbiological testing as well, which will, above are significant and compliance with one Union most likely, be restricted to a limited number of micro- does not necessarily mean compliance with the other. organisms, but in many cases will be done according to With regards to the Customs Union, food businesses statistically more stringent rules. Further, the tolerance and exporters should be prepared for extensive micro- limits between the two Unions may vary. Therefore biological testing for many microorganisms when they businesses wishing to export must understand how the present their products to the Customs Union market. regulations are organized and refer to specific criteria in For business operators and exporters who present their each particular case for each market place. Contaminants in Food Contaminant (European Union) or “potentially dan- In order to protect the health and well-being of consum- gerous substance” (Customs Union) generally means ers by ensuring the safety of food, both the Customs any substance not intentionally added to food which Union and the European Union have established a num- is present in such food as a result of the production ber of regulations to control the types and quantities of (including operations carried out in crop husbandry, contaminants found in food. The Customs Union, as animal husbandry and veterinary medicine), manu- part of the end-product conformity assessment process, facture, processing, preparation, treatment, pack- has developed a combination of vertical and horizontal ing, packaging, transport or holding of such food, technical regulations that establish the requirements on or as a result of environmental contamination15. contaminants in foodstuffs. The Customs Union tech- Contaminates can include toxic elements such as lead nical regulations combine general requirements set for and mercury, pesticides (DDT), chemicals (melamine all foodstuffs in a horizontal CU TR 021/2011 “On Food and dioxin), naturally occurring substances (aflatoxin), Safety”18 plus additional requirements which have been and in the Customs Union can include such things as established for milk and dairy products19, meat and hydrocyanic acid, radionuclides, and methyl alcohol16,17. meat products20, fats and oils21, juice products22, grains23, Since contamination is generally considered to have a food for special diets24. Additional specifics on food negative impact on the food safety and may imply a risk contaminants are detailed in the Uniform Sanitary and to human health, governments take measures to mini- Epidemiological and Hygienic Requirements for prod- mize contaminants in foodstuffs. ucts subject to sanitary and epidemiological supervision 15 Article 1.1, Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food and is similar to implied meaning within the Customs Union for “potentially dangerous substances”. 16 Extraneous matter, such as, for example, insect fragments, animal hair, etc., is not covered by this definition. On further analysis, it is im- portant to note that contaminants do not include physical impurities. 17 In some of the Customs Union technical regulations, “potentially dangerous substances” are listed as an independent list of substances; in other technical regulations, they are part of “hygiene safety requirements”; in the former case, hygienic safety requirements also cover other aspects or chemicals added to the foodstuffs, or objects that are present in food but are not contaminants. 18 Note that amendments are being prepared for the CU TR 021/2011; the period for collecting public comments has finished on July 3, 2014. For details of draft amendments, see http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/tr/Pages/10_04_2014_project.aspx . 19 Customs Union Technical Regulation CU TR 033/2013 “On Safety of Milk and Dairy Products”, Annex 4. Permissible levels of oxidative deterioration and content of potentially dangerous substances in dairy products, dairy composite products for nutrition of pre-school and school-age children. 20 Customs Union Technical Regulation CU TR 034/2013 “On Safety of Meat and Meat Products”, Annex 3. Hygienic Safety Requirements of Slaughter Products Intended for Infant Foods. 21 Customs Union Technical Regulation CU TR 024/2011 “Technical Regulation on Oils and Fats”, Annex 1. Requirements to permissible levels of food safety indicators of oil and fat products”. 22 Customs Union Technical Regulation CU TR 023/2011 “Technical Regulation on Fruit and Vegetable Juice Products”. 23 Customs Union Technical Regulation CU TR 015/2011 “On Safety of Grain”. 24 Customs Union Technical Regulation CU TR 027/2012 “On Safety of Special Types of Specialized Foodstuffs, Including Medical Diet Foods and Preventive Diet Foods” Comparative Analysis of Certain Requirements of Food Legislation in the European Union 88 and the Customs Union of Russia, Belarus, and Kazakhstan (control)25 (however one should remember that the contaminants. Maximum limits of contaminants are al- Uniform Sanitary Requirements are not applicable to the ways a product/contaminant combination; maximum products for which product-specific technical regula- limits are not established for each product/contaminant tions have been developed); specific requirements are combination, instead, they are established based on the based on the national laws of member states and on principle whether a substance can be present in the international requirements. In the European Union the product. The technical regulations also establish that approach to the legislation on control of contaminants sampling and testing for compliance with hygiene safe- is purely horizontal: all requirements to contaminants in ty requirements shall be done using rules and methods food are consolidated in one Regulation (EC) 1881/2006 listed in the List of standards containing the rules and on maximum levels of contaminants in foods26 and are methods of examination (testing) and measurement, in- developed according to a common unified procedure cluding the rules for sampling that are required for ap- which is applied across all member states. plication and meeting of the requirements of technical regulations and carrying out of assessment (confirma- To prevent food with dangerously high level of contami- tion) of products’ conformity28. nants entering into the market place, maxim limits27 for contaminants are established. These limits are based on The European Union Regulation (EC) 1881/2006 on toxicological studies that determine how much of the maximum levels of contaminants in foods covers a substance can cause negative effect on human health, wide variety of foodstuffs, but the range of foodstuffs given the amount of consumed product(s) containing is less than that in the Customs Union. The maximum such substance. The threshold amount of substance that limits are established based on the available Codex can be safely consumed according to the toxicological Alimentarius standards, and the opinions of the Scientific studies is called TDI (tolerance daily intake), ADI (accept- Committee on Food (SCF) and European Food Safety able daily intake), and ARfD (acute reference dose for a Authority (EFSA). The approach to identification of the one-time consumption of a large quantity of the sub- food categories and specific contaminants for which stance). TDIs are established for harmful chemicals that maximum limits are established is based on the vulner- cannot be avoided (e.g., contaminants that come from ability of the target group of consumers, the likelihood environment); ADIs are established for harmful chemi- of occurrence of a contaminant in a specific foodstuff, cal substances content of which in food can be man- the toxicity of contaminants, and consumption patterns aged through good practices (e.g. pesticides). Therefore in the European Union. the establishment of ADIs, TDIs and AEfDs are expected to be scientifically objective as they are based on thor- In some cases the food categories are divided into sub- ough toxicological research of mammalian reactions to categories depending on additional specific criteria or chemical substances. As such these studies are always risk factors related to the manner of production, pro- conducted on animals and then extrapolated to humans cessing techniques applied, and/or readiness for use. using several safety factors. Due to these safety factors, For example, whether the plant origin products were in practice, maximum limits for contaminants are estab- grown in the open air or under cover (e.g., in a green- lished well below the thresholds at which a negative im- house), and in what season (cold or hot): such criteria pact on human health is possible. for the grouping food products are used for establishing the maximum levels of nitrates in lettuce as an example, Within the Customs Union food products cannot be as the growth conditions can significantly impact the put into circulation at the market if they do not comply concentration of nitrates29. Regulation (EC) 1881/2006 with “hygiene safety requirements” which mainly cover also established other rules for food business operators 25 Uniform Sanitary and Epidemiological and Hygienic Requirements for products subject to sanitary and epidemiological supervision (con- trol). Chapter II, Part 1. Requirements for safety and nutrition value of food products. 26 Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs. 27 In Codex Alimentarius documents, it is common to use the word “limit” (maximum residue limit); in the EU documents, the word “level” (maximum residue levels) is commonly used. They designate the same concept. 28 Such Lists are approved for each food-related technical regulation of the Customs Union. 29 Another example is whether the products are ready for consumption as such or are subject to further process steps, for example sorting, as in some cases sorting technics may reduce the level of contaminant. In particular, such approach is adopted for setting maximum levels of mycotoxins, in particular aflatoxins in nuts, including hazelnuts. Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 89 in addition to the requirement to comply with the maxi- in cases where the values of maximum limits dif- mum levels of contaminants, as well as requirements fer between the Unions it is difficult to determine for foods that do not comply with the maximum levels. the reasons and explanations of the differences.  Specific MRL values in some cases are the same In general in the CU and the EU many of the contami- in the Customs Union and the European Union, nants for which maximum levels are established are and in other cases they differ. For example, with regard to patulin in apples, in the Customs Union similar. There are some differences such as toxic ele- the limits are set for apples and all product thereof ments, harmful impurities or impurities of metal, and (0.05 mg/kg). In the European Union the MRL on radionuclides Cesium-137 and Strontium-90; those are patulin is set for solid apple products, including only covered by the Customs Union30. There are others apple compote, apple puree intended for direct such as methyl alcohol, caffeine, and quinine that are consumption at 25 μg/kg (0.025 mg/kg), which is covered by the Customs Union regulations on contami- twice lower than in the Customs Union. nants (i.e., specific sections of technical regulations or  In multiple cases, when in both the European their annexes), but in the European Union they are ex- Union and the Customs Union MRLs are estab- cluded from regulations on contaminants and are cov- lished on the same contaminant, their scope ered by other regulations instead. covers different products. For example in the case of patulin, the Customs Union MRL in addition There are several additional differences between the to apples covers tomatoes and products thereof; Customs Union and the European Union in the area in the EU no MRLs on patulin are established for tomatoes and relevant products. of maximum residue limits that must be considered by businesses wishing to export and governments wishing  In the Customs Union the unit of measure used to model either Union’s requirements. to express values of maximum levels is mg/kg; (milligrams per kilogram) in the European Union  In the Customs Union foodstuffs are organized the unit of measure is μg/kg (micrograms per ki- into categories/subcategories for the purposes logram). Conversion between units is a factor of of contaminants MRLs based on the same crite- 1000. However, readers must be attentive to units ria/principles as for other hazards in food. In the of measure as this is a significant difference. European Union, in some cases additional crite- ria were introduced to categorize foodstuffs for  The law of the Customs Union does not establish the purposes of setting MRLs on contaminants, any specific rules on contaminants, other than the for example, whether the product is subject to responsibility to observe the MRLs. The European handling or processing techniques that can re- Union law establishes additional requirements on duce the level of contamination, and therefore it the Community monitoring and reporting, the is important to correctly determine the food cat- rights to temporarily suspend MRLs, and specific egory the product falls within. rules on food that fails to meet MRLs.  In the European Union, Regulation (EC) 1881/2006  In the Customs Union, most of food products, includes references on relevant TDI (tolerance especially primary products are covered by MRLs daily intake) or ADI (acceptable daily intake) based on radionuclides. In the European Union ra- on which maximum levels of contaminants were dionuclides are not considered a concern, and established for specific food categories and sub- MRLs apply only to mushrooms imported from categories. The TDIs and ADIs are listed in the certain countries that suffered consequences of Preamble of the Regulation (EC) 1881/2006, as Chernobyl nuclear plant disaster. well as sources of information (specific scientific Since there is a significant number of case-by-case dif- studies done based on risk assessment principles). ferences between the MRLs established in the Customs Maximum levels established by the Customs Union and the European Union, it is important that busi- Union technical regulations are based on scien- ness operators and exporters consult relevant legal acts tific research as well, however, since no scientific studies or TDIs/ADIs are referenced within the for specific MRL values prior to exporting to the respec- technical regulations and are not readily available, tive markets. 30 Radionuclides in the European Union are only controlled in mushrooms supplied from third countries affected by the consequences of Chernobyl nuclear plant disaster. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 90 and the Customs Union of Russia, Belarus, and Kazakhstan Maximum Residue Limits (MRLs) for Residues of Pesticides The yield of agricultural and horticultural crops can be amount that can be safely consumed. Where through severely reduced as a result of infestation by pests and the toxicity studies it has been established that a sub- diseases. In order to protect crops before and after har- stance demonstrates mutagenic (can cause gene mu- vest, plant protection products are used. Plant protection tations), carcinogenic (can cause cancer) or teratogenic products (this term is commonly used in the European (can damager fetus) effect, the substance is not autho- Union), or pesticides (the term is popular in the Customs rized for use. When an ADI or TDI for the substance Union) (insecticides, fungicides, herbicides), are chemi- is established, it is valid for all of the foods containing cal formulations containing an active substance and the substance and does not change between foods. other ingredients. Active substances are substances or However, the MRL for the substance will differ from food microorganisms including viruses, having general or product to food product, because MRLs are established specific action against harmful organisms and are the based on exposure and other factors. Instructions on essential components of plant protection products. application of pesticides (including how and how much to apply, when to apply, and how many days before the Plant protection products or pesticides include insec- harvest) are designed to ensure that MRLs are met. ticides, acaricides, herbicides, fungicides, plant growth regulators, rodenticides, biocides, etc. Pesticides are It is important to understand that the totality of the re- used to kill, repel or control pests; influence the life pro- quirements on pesticides in general includes three cesses of plants; destroy weeds or prevent their growth; sets of requirements: pesticide approval procedures and/or preserve plant products. Pesticides could have addressed to manufacturers, suppliers, importers of severe undesirable effects if they are not strictly regu- pesticides; requirements on application of pesticides lated. Therefore governments establish maximum resi- addressed to farmers or entities involved in production due limits (MRLs) for pesticide residues in food; MRLs are of primary products; and maximum residue limits (as a always established for a combination of specific food category of food safety criteria) addressed to all groups product and active substance of a pesticide. including food manufacturers. Requirements on en- forcement are usually a part of general official control Using one active substance many various pesticides can procedures. be produced, so the total number of pesticides globally is significantly greater than the number of active sub- In order to ensure the health and wellbeing of consum- stances. MRLs for pesticides are based on their active ers, the Customs Union and the European Union regu- substances and are established according to scientific late and set limits for pesticide residues in food. The studies. The best practice and a recommendation of the Customs Union combines general horizontal regulation Codex Alimentarius Commission is to base such studies CU TR 021/2011 “On Food Safety”31 with product-specif- within the framework of risk assessment. ic technical regulations. Further, two parts of Chapter II of Uniform Sanitary and Epidemiological and Hygienic ADIs/TDIs and ARfDs are key to indicate safety of a sub- Requirements for Products Subject to Sanitary and stance. Based on the ADI/TDI, a maximum residue level Epidemiological Supervision (Control) include require- (MRL) for the substance in the crop is established. The ments on pesticides32. The requirements are developed MRL is always lower than ADI or TDI (note that ADI/ on the basis of the legislation of the Customs Union TDI is set for a kilo of body weight). The MRL cannot be Member States and effective international law docu- higher than the ADI/TDI as the residue would exceed ments. The European Union has a significant number 31 Customs Union Technical Regulation 021/2011 “On Food Safety” (for all food products), Annex No. 3. Hygienic Safety Requirements for Food Products. 32 Two parts of Chapter II of Uniform Sanitary and Epidemiological and Hygienic Requirements for Products Subject to Sanitary and Epidemiological Supervision (Control) cover pesticides as well: Part 1. Requirements for safety and nutrition value of food products, Part 15 “Requirements for Pesticides and Agrochemicals”, and Part 1 (on food safety and hygiene requirements) of Chapter II of the Unified Sanitary Requirements similar to the technical regulations mentioned above, establishes the requirements as to the presence in food of banned pesticides. Part 15 establishes procedures for the approval of pesticides and MRLs for pesticides. Note that Part 1 does not apply where product-specific technical regulations exist. Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 91 of horizontal legislation that relates to approval33, MRLs34, environment, and therefore to ensure the safety of con- and use of pesticides35. The use of broad horizontal leg- sumers, pesticide regulations shall apply to feed as well36,37. islation provides the member states with a common platform creating a harmonized system across the EU. In order for a pesticide to enter the market place, both The purpose of the harmonization is to ensure protec- Unions have established authorization and MRL deter- tion of consumers while facilitating internal and external mination procedures. At a high level these procedures trade, encouraging a reduced use of pesticides and a include similar activities in that the manufacturer must wider application of good agricultural practices, as well prepare a dossier of information that establishes that the as increasing consumer awareness of the pesticide resi- product is functional, includes safety data, actual residue dues and the possible risk. levels in the product as well as in air, water, and soil, and specific product samples for use. This data is then evalu- From the perspective of the scope, legal acts in both ated by appropriate authorities, MRLs are established, and Unions cover a broad range of plant and animal food- lists of active substances and pesticides are published. stuffs including raw and processed products for which pesticide MRLs are established. In both Unions MRLs are The differences between the Customs Union and the set with respect to the impact on the environment (soil, European Union are found in the details. water and air), their impact on humans at all levels of use  In the Customs Union authorization of a pesti- including people engaged in application as well as the lo- cide is conducted according to the laws of each cal surrounding population, and the impact on non-target member state. While there is a general authori- animals, insects, and plants. The Customs Union only ap- zation process established38, each member state plies the pesticide MRLs to food whereas in the European authorizing body has the responsibility to follow Union the pesticide MRL requirements also apply to feed. the laws of their nation. In the European Union there is a common uniform system for authori- This broader expansion of the legal scope to feed in the zation for all member states with the risk assess- European Union is in recognition that segregation of plant ment being carried out by a single agency – the products such as grains for application only as feed or food European Food Safety Authority (EFSA). is difficult if not impossible under the current agribusiness 33 Evaluation, marketing, use and lists of approved substances: Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, and Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Two regulations on implementation, Directive 91/414. Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I, Commission Regulation (EC) No 1095/2007 of 20 September 2007 amending Regulation (EC) No 1490/2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and Regulation (EC) No 2229/2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC. 34 MRLs: Regulation (EC) NO 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC, Setting data requirements for active substances: Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market . Setting data requirements for plant protection products: Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. 35 Marketing of plant protection products: Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the plac- ing of plant protection products on the market. Sustainable use of pesticides: Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides. 36 Article 2 of Regulation (EC) No. 396/2005. 37 There are a few exclusions to the application of Article 2 of Regulation (EC) No 396/2005. This Regulation shall not apply to the products where it may be established by appropriate evidence that they are intended for: the manufacture of products other than food or feed; or sowing or planting; or activities authorized by national law for the testing of active substances. Maximum residue levels for pesticides set in accordance with this Regulation shall not apply to products intended for export to third countries and treated before export, where it has been established by appropriate evidence that the third country of destination requires or agrees with that particular treatment in order to prevent the introduction of harmful organisms into its territory. 38 The basic framework and criteria of the safety, toxicological and hygiene assessment are described in Part 15 of Chapter II of the Uniform Sanitary Requirements. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 92 and the Customs Union of Russia, Belarus, and Kazakhstan  In the Customs Union the submitted data must to the appropriate authorities for consideration, but include information on the nutrition value and no reference to GAP is made. organoleptic properties (in addition to safety data)  Both Unions provide lists of active ingredients. In of food products for which the specific MRL is the Customs Union this list contains approved and applicable. The European Union process is fo- non-approved substances (e.g., DDT is listed as cused only on risk to humans, environment, and well) and it is unclear which are approved or not non-intended organisms, and therefore changes approved40. In the European Union lists of active in organoleptic properties are not a part of the as- substances and their MRLs are compiled into a sessment and are instead left to the market place database. The database contains a history of each to determine their acceptability. authorization, so pesticide active substances that  The risk assessment process in the European were once authorized but subsequently lost their Union provides that if a substance is determined authorization, or did not pass the safety assess- to be a carcinogen, mutagen, endocrine disrup- ment can be found there as well, but their status tor, substances toxic for reproduction or is very is clearly marked. The EU Commission maintains persistent, it shall not be approved, unless expo- this database as a web-based portal of pesticides sure to humans is negligible. It is unclear if this and actives substances41. aspect is a part of the Customs Union risk assess-  In the Customs Union, MRLs are set only for ment process for pesticide authorization. those crops, for which a pesticide has been ap-  In the Customs Union the pesticide manufacturer proved. To the contrary, in the European Union, must provide data that establishes the acceptable MRLs are set for the crops for which pesticides daily intake (ADI). In the European Union the data are approved (in most cases, as a definitive MRL) must include data that establishes ADI, acute tox- and for all other crops as default MRLs of 0.01 icity (AT) with the Acute Reference Dose (ARfD). mg/kg (at the lowest level of analytical determi- These require a broader set of analysis and test- nation). This means that in the European Union ing by the manufacturer. the number of MRLs is significantly greater which  Importantly, clause 5 of Part 15, Chapter II of the creates stronger basis for monitoring. Customs Union Uniform Sanitary, Epidemiology  There are significant numbers of case-by-case and Hygiene Requirements states that “when differences with regard to specific MRL levels no MRL for a pesticide in a certain food is estab- as set by the Customs Union and the European lished, and/or there is no approved analytical test Union regulations. There also are differences in method for its active substance, such food (crop) ADI levels based on which MRLs are established. cannot be listed as crop for which application of the pesticide is approved”. This places the burden For potential exporters of agricultural products and on the manufacturer to submit and gain approval food to either market it is key to understand and meet for test methods for the active substance. There the current pesticide MRLs established for the specific are no similar requirements within the European commodities. The exporters of agricultural crops need Union in that test methods for active substances to know which pesticides are authorized at the target can be based on a variety of standards or new test market and what are the MRL requirements at the stage methods as long as they meet the requirements of procedures on establishing analytical methods. of growing or production of other primary agricultural commodities. For those who are involved in agricultural  A key intention of the European Union is to reduce pesticide risks through the use of good agricultural production connected with application of pesticides, it practices (GAP); data for the use of a pesticide is is equally important to get familiar with the national pes- based on its application according to GAP39. Within ticide authorization lists of the Customs Union mem- the Customs Union the manufacturer determines ber states before they begin the production intended for the use and application rates and provides those export. 39 Good Agricultural Practices are a collection of principles to apply for on-farm production and post-production processes, resulting in safe and healthy food and non-food agricultural products, while taking into account economic, social and environmental sustainability. They include a range of practices that cover soil, water, crop and fodder production, crop protection, animal production, animal health and welfare, harvest and on-farm processing, energy and waste management, human welfare, health and safety, and wildlife and land use. These are voluntary in the European system and are tailored to the specific type of and size of production. 40 Annex 15.1“Hygienic Standards for Concentration of Pesticide Active Substances in Environmental Objects, Food Raw Material and Food, Part 15 Chapter II of the Uniform Sanitary and Epidemiological and Hygienic Requirements for Products Subject to Sanitary and Epidemiological Supervision (Control). 41 http://ec.europa.eu/sanco_pesticides/public/?event=homepage Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 93 Maximum Residue Levels for Residues of Pharmacologically Active Substances The primary purpose of the legislation on pharmaco- major transmission pathway for resistant bacteria from logically active substances used in veterinary medici- food animals to humans. The consequences of antimi- nal products is to ensure the protection of consumers crobial resistance are particularly severe as pathogens against possible harmful effects resulting from exposure that are resistant to antimicrobials develop and flourish. to residues of veterinary medicinal products present in Antimicrobial resistance is an increasingly serious threat foodstuffs. These negative effects can be due to chemi- to global public health. AMR develops when a micro- cal toxicity of some veterinary medicinal products, and organism (bacteria, fungus, virus or parasite) no longer most importantly, when antimicrobial substances in- responds to a drug to which it was originally sensitive. cluding antibiotics are used - due to the development This means that standard treatments no longer work; of resistance to antibiotics in bacteria. Many antibiotics infections are harder or impossible to control; the risk of used on animals are the same as those used in humans. the spread of infection to others is increased; illness and Because bacteria become resistant, it is more difficult to hospital stays are prolonged, with added economic and treat human disease with antibiotics. social costs; and the risk of death is greater—in some cases, twice that of patients who have infections caused Generally, antibiotics can be administered to animals by non-resistant bacteria. The consequences of antimi- (such administering sometimes is referred to as “non- crobial resistance are particularly severe when patho- human use”) for two major purposes: for therapeutic gens are resistant to antimicrobials critically important reasons, i.e., to treat a disease, and in the form of a feed in humans44,45. additive to promote growth. Certain antibiotics, when given in low, sub-therapeutic doses, are known to im- The importance of control of pharmacologically ac- prove feed conversion efficiency (more output, such tive substances is a significant area of emphasis for the as muscle or milk, for a given amount of feed) and/or Customs Union and the European Union. This is by may promote greater growth, including by affecting gut far the most complex area of comparative analysis and flora42. therefore the most difficult. Due to the complexity and significant differences this section will focus on those According to OIE, over 60 % of human infections are areas that are the most relevant to the reader. A more zoonotic in nature43. As established by FAO, WHO and detailed analysis can be found in the expanded com- OIE, there is a clear evidence of adverse human health panion report and its annexes. Further, due to the com- consequences due to resistant organisms resulting from plexity it is important to note that for business operators non-human usage of antimicrobials including antibiot- wishing to export to one or both of the Unions they ics (antimicrobial resistance (AMR)). These consequenc- must first conduct an in-depth analysis of the require- es include infections that would not have otherwise ments of each Union prior to export. For governments occurred, increased frequency of treatment failures it is possible to model one or the other of the Unions but (in some cases death) and increased severity of infec- it would be impossible to harmonize the system in such tions. Evidence shows that the amount and pattern of a way that a single set of regulations would meet the non-human usage of antimicrobials have an impact requirements of both Unions simultaneously. on the occurrence of resistant bacteria in animals and on food commodities and thereby human exposure The differences begin with how pharmacologically ac- to these resistant bacteria. The foodborne route is the tive substances are defined and interpreted within the 42 The Merck Veterinary Manual. Growth Promotants and Production Enhancers. Available at: http://www.merckmanuals.com/vet/pharma- cology/growth_promotants_and_production_enhancers/antimicrobial_feed_additives.html#v4694978 43 OIE Bulletin. Veterinary and Medicinal products. No.2010-1. 44 Joint FAO/OIE/WHO Expert Workshop on Non-Human Antimicrobial Usage and Antimicrobial Resistance: Scientific assessment. Geneva, December 1 – 5, 2003. 45 Joint FAO/OIE/WHO Expert Workshop on Non-Human Antimicrobial Usage and Antimicrobial Resistance: Scientific assessment. Geneva, December 1 – 5, 2003. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 94 and the Customs Union of Russia, Belarus, and Kazakhstan two Unions. The technical regulations and other legal acts of the Customs Union do not establish any defini- tions relevant to pharmacologically active substances or their residues or maximum residue levels. The wordings that are commonly used are “veterinary preparations” “residues of veterinary preparations” and “acceptable levels of residues”. When acceptable levels of “residues of veterinary preparations” are established, actually they are established for active substances. In all other cases when requirements refer to veterinary preparations, what is meant is the entire drug which includes inserts and additives (adjuvants), not only its pharmacologically active substance itself. The European Union law clearly defines the terms “residue”46, “maximum residue limit”47 and “residue of pharmacologically active substance”48. In fact, “acceptable level of residue of veterinary prepa- ration” (as used in the Customs Union legal acts) means the same as the term “maximum residue level (MRL) of pharmacologically active substance” as used in the European Union law. However, in all other cases “veteri- nary preparation” (Customs Union) is not equal to “phar- macologically active substance” (European Union). This The problem (AMR) is so serious becomes important as one conducts an analysis to de- that it threatens the achievements of termine if a specific pharmacologically active substance modern medicine. A post-antibiotic is allowed in either Union, as the terms cannot be used era— in which common infections interchangeably and great care needs to be taken in the and minor injuries can kill—is a very reading and determining what is or is not approved. real possibility for the 21st century. 46 Article 2(c), Council Directive 96/23/EC of 29 April 1996 on mea- ANTIMICROBIAL RESISTANCE Global sures to monitor certain substances and residues thereof in live Report on Surveillance WHO 2014 animals and animal products and repealing Directives 85/358/ EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/ EEC. “Residue” means a residue of substances having a phar- macological action, of their metabolites and of other substances transmitted to animal products and likely to be harmful to human health. 47 Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maxi- mum residue limits of veterinary medicinal products in foodstuffs of animal origin. “Maximum residue level” means the maximum concentration of residue resulting from the use of a veterinary medicinal product (expressed in mg/kg or μg/kg on a fresh weight basis) which may be accepted by the Community to be legally permitted or recognized as acceptable in or on a food. 48 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community proce- dures for the establishment of residue limits of pharmacologi- cally active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council. “Residues of pharmacologically active substances” means all pharmacologically active substances, expressed in mg/ kg or μg/kg on a fresh weight basis, whether active substances, excipients or degradation products, and their metabolites which remain in food obtained from animals. Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 95 Each Union has a specific set of regulatory instruments a preparation that is approved in Russia may not be ap- that are used to control pharmacologically active sub- proved in Kazakhstan. stances, their approval, registration, MRLs, specific uses and publication of their lists. In the Customs Union rel- The European Union has established a uniform set of evant legal acts are based on horizontal technical regu- horizontal laws for all 27 member states that covers lations49, vertical technical regulations50 and other legal authorization and supervision of pharmacology active instruments51. The Customs Union regulations are aug- products54, MRLs55, monitoring56 and marketing57 of mented by national laws of the member states on is- these products as well as a specific ban on antimicro- sues where the CU regulations are not established. This bial growth promoters58. Through this uniform set of augmentation applies to authorization and registration laws and regulations the European Union ensures free procedures for pharmacologically active substances trade among the member states, supports exports, en- or veterinary preparations, establishment of MRLs, and courages the use of pharmacologically active substance placing substances to the authorization lists52. The in a manner that minimizes the risk of their presence Customs Union does not publish a list of banned or through reduced use, promotes application under good prohibited substances, however the following general agricultural practices and consumer awareness of the rule applies: when a substance is not authorized then pharmacology active substances and the possible risk it cannot be used. The Customs Union list53 of autho- they pose. rized veterinary preparations is in fact a set of links to the three lists of member states. In addition, member In the Customs Union the requirements on presence states’ national registration lists of veterinary prepara- of residues of pharmacologically active substances tions in most cases do not specify active substances are established for both raw material and processed for the registered preparations (except for in Russia), ready-to-eat food of animal origin, including meat and which makes it difficult to determine if a specific active products thereof, milk and dairy products, eggs and substance is approved for use. Finally, in the Customs products thereof, fish and products thereof, and honey. Union Registration List which consists of the national Additionally, requirements are established for presences registration lists of the three member states some active of certain substances in food for babies and children, and substances can be registered in all three member states, food for pregnant and nursing women. In the Customs others in only one of them. Thus it is quite possible that Union requirements on residues are established for two 49 Customs Union Technical Regulation 021/2011 “On Food Safety” (for all food products). 50 Custom Union Technical Regulation CU TR 034/2011 “On Safety of Meat and Meat Products”. 51 Part 2 of Chapter II of the Uniform Sanitary, Epidemiology and Hygiene Requirements for Products Subject to Sanitary and Epidemiological Supervision (Control) sets maximum residues levels (MRLs) of pharmacologically active substances. 52 Uniform Sanitary, Epidemiology and Hygiene Requirements for Products Subject to Sanitary and Epidemiological Supervision (Control) establish a general requirement on putting together a single (uniform) list of therapeutic substances used in veterinary medicine, however it does not specify what minimum information shall be included into the list, or how it shall be maintained; the member states hold their national authorization lists according to their national procedures. 53 Ibid. 54 Regulation (EC) No 726/2004 that repealed Regulation (EEC) No 2309/935 lays down a Community procedure for the authorization and supervision of medicinal products for human and veterinary use and establishes a European Medicines Agency. 55 Maximum residues levels in the foodstuffs of animal origin are established by Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue levels in foodstuffs of animal origin. The establishment of the MRLs is conducted according to Regulation (EC) No 470/2009 on establishment of residue limits of pharmacologi- cally active substances in foodstuffs of animal origin. 56 Monitoring of presences of prohibited substances, including antimicrobial growth promoters, steroids, hormones is performed based on Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products. 57 The basic rules governing the marketing of veterinary medicinal products within the European Union are set by the codified Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. 58 A separate set of regulations establishes a ban on antimicrobials (antibiotics) that are used as growth promoters. Until the ban, they were used by adding them to animal feed. The ban was introduced gradually until they were phased out completely by Regulation (EC) No 1831/2003 on additives for use in animal nutrition. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 96 and the Customs Union of Russia, Belarus, and Kazakhstan types of active substances. The first group includes sev- eral antibiotics such as laevomycetin, tetracycline group, streptomycin, penicillin that are controlled in all raw material and food products, including processed ready- to-eat food (e.g., sausages, cheeses) of animal origin, whether it is produced inside the Customs Union or im- ported to its territory. For these antibiotics threshold lev- els are established at the level of analytical determination below which their residues are not allowed (and can not be found). The second group of substances covers ac- tive substances that are controlled for imported raw ma- terials and animal products at the point of entry to the Customs Union and upon their supply for processing, and only if a manufacture or supplier declares that they were used on food producing animals. According to the rules of entry into force of CU TR 034/2013 “On safety of meat and meat products”, MRLs on such substances enter into force when a list of regional standards that establish testing methods is compiled and published to support CU TR 034/2013. The list of standards has been published already, but at the time of writing it does not include specific testing methods. Laevomycetin (Chloramphenicol) is In the European Union, there is a single list of MRLs a potent, broad spectrum antibiotic established for active substances, which are controlled drug that is used to treat a variety of both in the products of animal origin produced within diseases in animals. It is authorized the European Union and imported from third countries only for use in Russia in animals regardless of whether they are intended to be marketed for dairy and meat and is not on as such or are supplied for further processing. the authorized lists for Belarus or Kazakhstan. In order to provide some insight into the complexity of rules on the use of pharmacologically active substances and their MRLs, below is a comparative summary be- tween the Customs Union and the European Union rules for the substances (antibiotics) that in the Customs Union are controlled in all food products of animal ori- gin, as well as substances that are not authorized in the EU but are registered in the CU (Table 3). This is only a non-exhaustive summary but it will give the reader some idea of the complexity of the area as well as the need to conduct a detailed analysis prior to exporting to either of the trading blocks. One should also be aware that there are certain discrepancies within technical reg- ulations of the Customs Union (they can be found in the main report). As was mentioned, within the Customs Union there is differentiation in the control of pharmacologically active substances. There is a general group that is controlled for all products (see above) and another group of sub- stances controlled on the basis of information on their Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 97 Comparison of Pharmacologically Active Substances that are controlled in the Customs Union in Table 3 all food products of animal origin, with the European Union Pharmacologically Customs Union European Union Comments active substance Laevomycetin Registered only in Prohibited In the Customs Union not allowed in all prod- (Chloramphenicol) Russia ucts at the level of analytical determination (LAD) <0.01 mg/kg (CU 021/2011); in meat and meat products at LAD <0.0003; and in milk and dairy products at LAD <0.0003 starting from 01.07.2015. In EU no MRL is established because the sub- stance is prohibited. Tetracycline group Registered in all Authorized In the Customs Union the threshold above member states which the residues are not allowed is <0.01 mg/kg. In the European Union MRL for milk and meat is 0.1 mg/kg. Penicillin and Registered Authorized In the Customs Union residue of penicillin is not derivatives allowed at the level of analytical determination of < 0,004 in milk (CU 021/2011); for meat and meat products MRLs are set for residues of each specific derivative (CU 034/2013). In EU MRLs are set for residues of each specific derivative in milk and meat Grizin Registration is un- Prohibited The substance is not registered in the Customs clear; presumably Union member states (unless it is registered not registered in under a trade name), however, in the Customs any of the member Union the residues are not allowed at <0.05 mg/ states kg in meat and poultry and product thereof. In EU no MRL is established because the sub- stance is prohibited. Dapsone, Registered Prohibited All substances except Dapsone registered at least Ronidazole, in one Customs Union member states, and a Dimetridazole, threshold at LAD of <0.1mg/kg is established. Nitrofurans (includ- In EU no MRL is established because the sub- ing furazolidone), stance is prohibited. Metronidazole Clotrimazole, Registration un- Prohibited Not registered in the members states of the Aminitrizole clear; presumably Customs Union (unless under a different trade (aminitrozole): not registered in name), and a threshold is established (not allowed any of the member at LAD <0.1mg/kg). states In EU no MRL is established because the sub- stances are not listed. Non-listing means no safety assessment has been done Bacitracin Registered only in Banned as a In the Customs Union not allowed in all meat Russia growth promoter; (including poultry), and products thereof at <0.02. Authorized as a In the European Union no MRL is established therapeutic drug because the authorized use is strictly restricted with the restrictions for lactating cows and also on rabbits Comparative Analysis of Certain Requirements of Food Legislation in the European Union 98 and the Customs Union of Russia, Belarus, and Kazakhstan use provided by the manufacturer (supplier) of slaughter Union market, because it would not be possible to meet products at the time when they are imported into the the Customs Union MRLs (as MRLs for non-target spe- customs territory of the Customs Union or supplied for cies extend to poultry). processing. In some cases European Union MRLs have broader The differences with regard to MRLs exist with approxi- scope (cover a wider range of animal species) than MRLs mately 20% of substances listed in the two Customs for corresponding substances in the Customs Union, or Union lists59 and the European Union MRLs list60. additional MRLs are set for certain animal species. These differences exist on a case-by-case basis. The Customs Union MRLs are generally harmonized with European Union MRLs on therapeutic substances In the cases where the differences are related to autho- (Regulation (EU) 37/2010) with some exceptions, and rizations of active substances, the EU requirements are with European Union MRLs on unavoidable carry-over stricter than in the Customs Union: several substances residues of pharmacologically active substances used that are registered in the Customs Union member states as feed additives in non-target animals (Regulation are prohibited in the European Union. Additionally, many (EC) 124/200961), but they are not harmonized with the substances authorized in the European Union have re- European Union MRLs on pharmacologically active strictions on their use, for example cannot be used on substances used as feed additives in target animals (in egg or milk producing animals. EU the MRLs for target animals are established in indi- vidual regulations approving each feed additive). The EU Within the group of substances controlled in the feed additives MRLs with which the Customs Union list Customs Union in case where the manufacturer (sup- is not harmonized, in all cases refer to different types of plier) of slaughter products declares their use during poultry and rabbits as target species. There are multiple importation or supplying for processing), the differences instances of such differences where it comes to MRLs exist with regard to the following substances. in meat, including poultry meat, and a few in case of MRLs in milk. Meat, including poultry meat:  Differences between the Customs Union and In most cases where differences exist between the European Union in MRLs for meat (muscle) of Customs Union and the European Union in MRL values, all food producing animal species, including MRLs of the Customs Union are stricter. This is due to poultry as relevant, with regard to the follow- the fact that the Customs Union MRLs are harmonized ing substances: apramycin (aminoglycosides), with European Union MRLs on unavoidable carry-over sarafloxacin (quinolones), monensin, lasalocid (ionophores), nitrofurans (including furazoli- residues of feed additives in non-target animals which done), metronidazole/dimetridazole, flavomycin are much lower than MRLs in target animals (this is be- (streptotricyn), diclazuril, nicarbazin, amprolium, cause when a feed additive is not intended for a cer- robenidine, narasin, salinomycin, halofuginone, tain species, it can only get into the non-target animals decoquinate. Differences relate to authorizations, through cross-contaminated feed; when a feed additive MRL values and MRL scopes in terms of animal is intended for a species, the animals consume much species covered. bigger amounts of the substance as it is directly given to  Many pharmacologically active substances list- them)62. Generally, it means that in such cases products ed in the European Union are authorized with that comply with the Customs Union MRL criteria, will restrictions on use; for example they cannot meet the European Union criteria as well. However, this be used on animals that produce milk or eggs also may mean that in reality some feed additives cannot for human consumption (Apramycin (amino- be used for poultry intended to be sold at the Customs glycosides), Paromomycin (aminoglycosides), 59 CU TR 034/2013 and Uniform Sanitary, Epidemiology and Hygiene Requirements (for the Customs Union). 60 Commission Regulation (EU) 37/2010 on MRLs of pharmacologically active substances in food. 61 Commission Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels for the presence of coccidiostats or histomono- stats in food resulting from the unavoidable carry-over of these substances in non-target feed. 62 The European Union MRLs on carry-over residues of feed additives in non-target animals are based on assumption that not more than 3% of feed is unintentionally cross-contaminated with the residues. Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 99 Kanamycin (aminoglycosides), Spectinomycin  Some pharmacologically active substances listed (aminoglycosides) all substances of sulfanilamide in the European Union are authorized with re- group (sulfanilamides), trimethoprim (diaminopir- strictions on use. imidin derivatives), thiamphenicol (florfenicols), florfenicol (florfenicols), flumequine (quinolones), Producers/importers targeting the Customs Union mar- ciprofloxacin / Enrofloxacin / pefloxacin / ofloxa- ket as well the European Union market must ensure that cin / norfloxacin (fluoroquinolones), sarafloxacin (quinolones), danofloxacin (quinolones), difloxa- their products comply with MRLs established for pharma- cin (quinolones), oxolinic acid (quinolones), spi- cologically active substances of therapeutic medicines ramycin (macrolides), tilmicosin (macrolides), and feed additives. To achieve this, it is important to check tylvalosin (macrolides), avilamycin, doxyciclin the MRL in the Customs Union technical regulations, (tetracyclines), benzylpenicillin / penethamate check the registration status of a veterinary preparation (penicillin group), Ampicillin (penicillin group), in the State Registration lists of the Customs Union mem- amoxicillin (penicillin group), cloxacillin (penicil- ber states, check if the substance is included into any lins), dicloxacillin (penicillins), oxacillin (penicillins), of the two MRL lists of the European Union, check if the diclazuril, toltrazuril. substance is approved in the European Union as a feed additive, and find an MRL of the substance for tissues/ products of the target animal(s). Checking relevant pro- Milk: visions of the Customs Union and the European Union  Lasalocid (ionophores), nitrofurans (including fu- legal acts is especially important for producers of poultry razolidone), metronidazole/dimetridazole, flavo- meat, as differences between the CU and EU are multiple mycin (streptotricyn), diclazuril. Differences relate and significant. Depending on the target export market authorizations and MRL scopes in terms of ani- producers may change their strategy of rearing the poul- mal species covered. try intended for export and decide not to use therapeutic drugs and feed additives as a part of the rearing regime. Approaches to Laboratory Control, Sampling and Testing The ability to provide safe food domestically and with products as well as roles and responsibilities, and ac- trading partners is a shared responsibility of govern- creditation of laboratories within their respective legal ments and industry. In order to deliver on this commit- frameworks63. Yet the focus of the two regimes is quite ment, governments and industry must have the ability different. Within the Customs Union testing, sampling to conduct specific measurements to demonstrate that and laboratories are a part of the overall conformity as- the systems and procedures of food control deliver a sessment process whose end-product is ensuring food safe products. These measurements range from such safety through documents establishing conformity to things as weight and fat content, to quantity of additives the technical regulations. In the European Union the or nutrients added to a product, to the ability to measure food safety system is designed on a risk-based process and determine quantities of pathogens, mycotoxins, approach to ensuring food safety through preventive heavy metals, pesticides, and pharmacologically active measures at all levels in the food chain from farm-to- substances. The ability to conduct repeatable, valid, and fork. To this end, in the European Union laboratories, accurate measurements is dependent upon laboratory testing and sampling provide an integral role in the es- controls, sampling and testing. tablishment and monitoring of risks throughout the pro- cess of official control. It is through the combination of The Customs Union and the European Union have establishing risks, controlling and monitoring these risks established defined sampling and testing regimes for that the European Union ensures the safety of its food 63 Customs Union Technical Regulation CU TR 021/2011 “On Food Safety”. Decision No 27 of 11 December 2009 CU agreements in the field of technical regulation further defines requirements for mutual recognition. Decision 834 of 18 October 2011 on the Regulation on the common procedure of joint inspections of objects and sampling of goods (products) subject to veterinary control Section X, line 133. Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, Title II Official Controls by Members States Article 12(1). Comparative Analysis of Certain Requirements of Food Legislation in the European Union 100 and the Customs Union of Russia, Belarus, and Kazakhstan and agricultural products. Further, the European Union  Within the Customs Union it is expected that incorporates enabling trade outside of the European each country have the capacity and capability to Union as a key element of their food safety program, provide the necessary laboratories required for all tests. As laboratories are expected to support the and therefore laboratories have a significant role in the conformity assessment process testing includes global community. In order to enable trade, laboratories product attributes such as weight, color, acidity are mandated to provide training and support specifi- as well as key food safety parameters such as cally to developing economies to ensure that the gov- microbial, heavy metals, pesticide residues, and ernments and industry have access to the proper tools pharmacologically active substances. This cre- to ensure the safety of products entering the European ates a significant burden on the countries both in Union64. terms of financial as well as technical resources68. In the European Union countries can leverage The differences in approaches to food control between resources or use laboratories of other countries the Customs Union and the European Union creates within the European Union. In this way, mem- specific differences between the Unions with respect to ber states can share the financial and human resource burden of laboratory control and thus laboratories, sampling, and testing. reduce the costs for each of the member states. Within the context of laboratory control there are several  Within the Customs Union it is implied but not specifically stated that National reference labora- differences that should be highlighted. tories should be established. Within the European  One of the keys to having a successful labora- Union reference laboratories are specifically es- tory program is to ensure that the laboratory tablished and funded69. These range from labora- maintains a quality system and the technical tories on food additives, GMO, BSE, melamine in competencies in order to conduct the appropri- milk and dairy products, to Salmonella and pes- ate tests. Within the Customs Union laboratories ticide residues70. Each of these laboratories plays are accredited by the appropriate National body a critical role in the food control program in the based on the national standards65. In this case European Union and globally as they are estab- the accreditation is at the sole discretion of the lished as global reference laboratories for many National Accreditation Body. In the case of the countries outside of the European Union. In this European Union laboratories also have to be ac- global role they develop new test methods, pro- credited by a third party. The European Union vide support to countries throughout the world in has established that laboratories must be accred- key technical areas, provide key support globally ited to the ISO 1702566 standard by a body that is for disease outbreaks, and provide training and internationally recognized, and it is not required knowledge transfer for laboratories in emerging that the national standards body provide the ac- markets as a way to help improve the laboratory creditation. Instead accreditation of the labora- capacity globally. During the Highly Pathogenic tory can be done by any body or organization Avian Influenza outbreaks Weybridge laboratory internationally recognized to carry accreditations in the United Kingdom provided critical support to ISO 1701167. In this way, laboratories within to countries throughout the world as initially they the 27 member states of the European Union are were 1 of only 3 laboratories globally that could held to the same uniform standard. test for this disease. 64 Regulation (EC) No. 178/2002, Commission decision of 12 August 2002 Regulation (EC) No 852/2004, implementing Council directive 96/23/EC, Regulation (EC) No 882/2004, Regulation (EC) No 852/2004, Regulation (EC) No 853/2004, Regulation (EC) No 854/2004. 65 Each of the members of the Customs Union has adopted a national standard for laboratory accreditation based on ISO 17,025. Russian Federation GOST-R 17025, Belarus STB ISO / IEC 17025-2007, and Kazakhstan ST RK ISO/IEC 17025-2007. 66 ISO/IEC 17025:2005 “General requirements for the competence of testing and calibration laboratories”. 67 Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, Article 12. 68 Based on work completed by T&M Associates globally. 69 Regulation (EC) No 882/2004 Title III Article 32, Community Reference Laboratories. 70 To find specific reference laboratories within the European Union check the link http://ec.europa.eu/food/food/controls/reference_labo- ratories/index_en.htm . Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 101 The need for adequate sampling is fully recognized and a representative sample of the totality of the ma- codified by the Customs Union71 and European Union72 terial. Sampling techniques, labeling, transporta- but sampling is not the same within the Unions. tion are clearly defined and take into account the difference between samples of animal, plant and  Within the legal framework of the Customs mixed origin as well as the state of the material Union sampling is a part of the conformity as- (liquid or solid). The European Union is specific sessment process. Sampling is done to ensure as to how results from the corresponding testing the product meets the requisite technical regu- are reported including uncertainty and determin- lations. Under the technical regulations, specific ing compliance. Sampling procedure takes into GOST standards and national standards of the account the specific target that is to be tested member states, sampling is carried out to sup- and the impact that temperature will have on the port the issuance of conformity documents. sample. Further, sampling is conducted at all lev- As such, samples are used to validate a variety els of the food chain domestically and for imports of parameters including pathogens, residues of based on risk using well defined sampling process pesticides, veterinary medicines, heavy metals, and procedures. Samples are taken to examine radionucletides, mycotoxins. While the need for products for pathogenic microorganisms73 in- sampling is defined in the Customs Union tech- cluding specific pathogens74, pesticide residues75, nical regulations, the procedure of sampling, or mycotoxins76, heavy metals77, nitrates78, pharma- in other words how the samples are to be taken, cologically active substances79, and pathogens80. by whom, what tools are to be used, sample  In the Customs Union sampling for domestic and size, the use of composite size, product sampling imported products is in fact conducted at the sole plans, etc. are not defined in the corresponding discretion of the inspector. Within the European GOST and national standards. This can create sig- Union sampling is performed to ensure that the nificant differences between the test results not controls under the HACCP program are effective. only from laboratory to laboratory but also from Inspectors take samples based on risks, sampling product sample to product sample. is done according to a unified set of sampling  Within the European Union sampling is linked to plans and procedures to ensure that samples are testing as it is recognized that the act of sampling consistent and uniform. is the single largest contributor to the reliability  In the Customs Union national sampling plans and accuracy of the test results. The European are not applied as the Union does not use risk- Union is very specific as to by whom samples are based approach as a basis for ensuring safe food. taken, what tools are used, how many samples, The European Union legislation provides for the preparation of composite samples to provide Community sampling plans that are tied to the 71 In the Customs Union there are two primary legal acts that provide the legal basis for sampling: technical regulation of the Customs Union CU TR 021/2011 “On Food Safety”, and Regulation on Common Procedure of Joint Inspections of Objects and Sampling of Goods (Products) subject to veterinary control (surveillance) (approved by Decision of the Customs Union Commission No. 834 of 18 October 2011). In addition, Regulation on a Procedure of State Sanitary-and-Epidemiologic Supervision (control) Over Persons, Vehicles, and Goods Crossing Customs Border of Customs Union (approved by Decision of the Customs Union Commission № 299 of May 28, 2010) provides the legal basis for sampling at borders. 72 Regulation (EC) No 882/2004, Article 10 establishes that sampling is a part of the official control activities and provides the legal basis for sampling. 73 Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs, Article 3. 74 See, for example, Guidelines on sampling the food processing area and equipment for the detection of Listeria monocytogenes, Version 3 – 20/08/2012, European Union Reference Laboratory for Listeria monocytogenes (EURL Lm). 75 Commission Directive2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide resi- dues in and on products of plant and animal origin and repealing Directive 79/700/EEC. 76 Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs. 77 Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs. 78 Commission Regulation (EC) No 1882/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of the levels of nitrates in certain foodstuffs. 79 Commission Decision of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products. 80 Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs Chapter 3. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 102 and the Customs Union of Russia, Belarus, and Kazakhstan risks. Each year thousands of samples are taken The most significant difference in testing between the and analyzed that are focused on understanding Customs Union and the European Union is in the ap- the risks of specific substances and general cat- proach to test methods. egories of substances.  Within the Customs Union test methods and spe-  The European Union recognizes that over time, cific requirements to testing are codified in the ap- taking into account progress in science, technol- proved lists to support each technical regulation ogy and methodology, emerging and/or new and are established in GOST standards (or other target biological or chemical hazards and infor- national standards that are approved regionally mation from risk assessments, there may be a within the Customs Union). While this does cre- need for review, and therefore the EU has a pro- ate a degree of uniformity, it also limits the labo- cess for amending requirements. ratories to use only specific approved methods. This limits or precludes the use of alternative test- Laboratory analysis which is the ability to identify and ing methods or new technology and therefore measure constituents of a foodstuff or feedstuff is criti- constrains the laboratories in their work as they cal to ensuring safe food. It is the analysis which pro- cannot use new methods which have been de- vides the basis by which declarations of conformity for veloped and validated by others. food products are issued in the Customs Union. In the  The European Union and its predecessor the European Union laboratory analysis provides the infor- EEC recognized that testing and the results that mation that is needed to ensure that risk-based food are obtained can have a critical impact on the control processes and systems are effective and deliver economies of the Union members. As such they safe food. Testing and analysis are highly interdepen- began a program to harmonize testing. But the dent upon laboratories and sampling, as without prop- European Union does not harmonize test meth- erly equipped and capable laboratories, or proper and ods themselves instead they developed a set of criteria by which test methods are to be estab- effective sampling, testing cannot provide the reliable, lished. So long as a test method meets the speci- reproducible, verifiable and accurate results required to fied criteria the method is considered to be valid meet their mission. as are the results and therefore they are accepted across the European Union. This gives the labo- The Customs Union81 and the European Union82 have ratories the freedom to use a variety of methods, an established legal basis for testing and analysis as part take advantage of new technologies for testing, of their food control program. In the Customs Union and provide the European Union with the ability testing (like sampling, as descried above) is established to adapt over time to emerging new risks. Further, as part of the conformity assessment process. In the the European Union sets rules for reporting results European Union analysis/testing is clearly established that include the use of uncertainty and measure- as part of the overall food control system. Further, the ment error and in this way can communicate the European Union establishes that analysis methods shall precision of the measurement. It is also required that validation of methods is carried out, includ- comply first with Community rules, second with inter- ing the use of multi-laboratory testing to establish nationally accepted protocols, and third with methods uncertainty and validity of the methods. that are developed in compliance with scientific proto- cols, thus providing flexibility to develop new test meth- ods as needed in the future. 81 Customs Union Technical Regulation CU TR 021/2011 “On safety of food products”, Articles 5 and 20 “Rules of Circulation on the Market”. 82 Regulation (EC) No 882/2004 of the European Union line 12 and Article 11. Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 103 Important Notes for Governments, Policy Makers and Businesses The Customs Union and the European Union have es- Transparency tablished rigorous controls over safety of food placed on their markets. They in general achieve objectives of food All food safety criteria should be based on sound sci- safety, but through fundamentally different approaches entific grounds. The Customs Union and the European and therefore very different legal frameworks, regula- Union have scientific framework applied for setting spe- tions, systems and procedures. The major differences cific requirements. However, in the Customs Union the relate to the following: source of specific provisions is the law of the member states, and scientific justifications are not publically avail- able. In the European Union decisions on establishing food safety criteria are taken at the Community level and Final product testing and conformity assessment in are transparent, including public availability of scientific contrast to prevention through a wide application justification for each criteria. of risk-based food safety systems (HACCP) For each group of hazards, for which food safety criteria The food safety criteria of the Customs Union are de- have been set, there are similarities and differences. The signed in a way that they are focused on testing of the differences are summarized below. final products for compliance with multiple regulatory requirements. The food safety criteria cover all food- stuffs and a lot of potential hazards with both high and low risk of occurrence, as well as agents in food that are Microbiological Criteria: not hazards per se, but can indicate the probability of the  Some of the microorganisms for which food is hazard occurrence. While in the Customs Union HACCP tested, are different between the Customs Union principles are a part of regulations as well, they in fact and the European Union. are integrated into the conformity assessment activity  In the Customs Union, to a much greater extent at a very limited level. The European approach to food the focus is made on testing for indicative micro- safety criteria, to the contrary, relies more on hazard pre- organisms; in the European Union, microbiologi- vention through HACCP, and testing requirements are cal safety criteria are established for pathogens. established for only those hazards that are significant  The microbiological requirements of the Customs for safety of a particular product. As a consequence the Union are focused on testing of the product be- food testing in European Union is more targeted, and fore it is put into circulation. The European Union the number of tests is reduced. law has established microbiological criteria to test for safety of products placed on the market during their shelf-life, and process hygiene crite- ria to test for acceptability of production tech- niques and processes. Responsibility  In some limited number of cases according to the Customs Union technical regulations micro- The Customs Union technical regulations set exhaus- biological criteria are used for the purposes of tive food safety criteria, and a manufacturer must ensure product identification. that the food he produces meets them. In the European  Some differences exist in sampling procedures. Union, it is a responsibility of a food business operator  Some differences relate to technical aspects, for to identify additional relevant food safety criteria beyond example with regard to units of measure. those established by regulations, and to develop control  The European Union has a special approach for them under a HACCP-based program. Further, with to control of Listeria monocetogenes in ready- regard to some of the food safety criteria, in particular, to eat food; this approach is not applied in the microbiological criteria, it is also a right of a food safety Customs Union authority to test the food for additional criteria in case of  The values of microbiological criteria differ in a food safety concern. some cases. Comparative Analysis of Certain Requirements of Food Legislation in the European Union 104 and the Customs Union of Russia, Belarus, and Kazakhstan Maximum Residues Levels for Residues of Contaminants: Pharmacologically Active Substances:  Generally, the Customs Union legal acts establish  There are significant procedural differences with a much wider list of contaminants than European regard to registration and approval of veterinary Union; there also is a difference in the products drugs and establishing MRLs for pharmacologi- covered by maximum levels (MLs): in the Customs cally active substances between the Customs Union MLs on contaminants are set for almost all Union and the European Union. foodstuffs; while in the European Union this list is  In the Customs Union, safety data and evalua- quite large but it does not cover all food. tion summaries for the approved substances are  The most significant differences in specific con- not in the public domain. In the European Union taminants for which MRLs are established is radio- such information is publically available. nuclides. Radionuclides are controlled in a wide  There are significant differences with regard range of food products in the Customs Union, to prohibited substances and control of their but only mushrooms from certain countries are residues in food of animal origin between the controlled for radionuclides in the European Customs Union and European Union. Union.  In the Customs Union, a limited number of phar-  There are case-by-case differences between spe- macologically active substances are controlled cific MRLs established in the Customs Union and in all food of animal origin as part of conformity European Union regulations. assessment, and the majority are controlled in  The Customs Union does not establish additional raw material according to information of their procedures on contaminants addressed to the use upon entry into the Customs Union or upon Member States. In the European Union law ad- supply for processing. In the European Union, all ditional procedures are established for example, pharmacologically active substances are con- community monitoring and reporting. trolled uniformly regardless the product is pro- duced locally or imported.  The majority of MRLs in the Customs Union are harmonized with the European Union MRLs es- Plant Protection Products (Pesticides): tablished for pharmacologically active substances  Pesticide MRLs in the Customs Union only cover of therapeutic drugs, and MRLs for unintentional food. In the European Union they also cover feed carry-over of pharmacologically active substanc- as it is recognized that segregation of feed such es used in feed additives into non-target animals as grains between those intended for humans through cross-contaminated feed. However, the and for animals is not possible under the current Customs Union MRLs differ significantly from EU agribusiness regime. MRLs with regard to pharmacologically active  There are differences in authorization procedures substances used in feed additives for target ani- and setting of MRLs. In the Customs Union this mal species. This creates a situation where in the is done according to the procedures of member Customs Union the MRL values are significantly states and in the European Union according to lower in many cases versus the European Union. a multi-stage procedure that includes both the This in practice can make it impossible to use member state and the Community level. certain feed additives during production of cer- tain animal species (in most cases poultry/broiler  Scientific justification for pesticide MRLs are pub- meat) when they are intended for the Customs lically available in the European Union and are Union market. not available in the Customs Union.  There are significant differences between the  For food products for which MRLs are estab- Customs Union and European Union in MRLs for lished the most important difference is that in poultry meat and only few differences in MRLs the Customs Union MRLs are set only for those for milk. crops, for which a pesticide has been approved. In the European Union, MRLs are set for the crops  When determining which MRL applies to your for which pesticides are approved as specific product, a special attention should be paid to the MRLs and for all other crops and primary prod- scope of MRLs established by relevant legal acts ucts (including of animal origin) as default MRLs of both the EU and the Customs Union (in terms of 0.01 mg/kg (at the lowest level of analytical of animal species covered and target organs/ determination). This means that in the European products). Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 105 Union the number of MRLs is significantly great- assessment and issuance or declarations of conformity er, which creates stronger basis for monitoring. regards laboratories, sampling, and testing as the most  There are case-by-case differences with regard to important tool to determine conformity. Further, the specific MRL levels as set by the Customs Union Customs Union provides limited specificity as to how and European Union regulations. There also are laboratories are to operate and what competencies are differences in ADI levels (toxicological parameter required. Similarly sampling is limited in specificity as of acceptable daily intake) based on which MRLs to how many samples are taken, where the product is are established, which means that scientific data sampled, what tools the product is sampled with. The used to establish MRLs is not similar. For poten- Customs Union does not describe how many samples tial exporters of agricultural products and food to either market the most important is to be aware are to be taken depending on the nature of the sam- of the current pesticide MRLs established for their ple, the matrix of the sample, or the state of the sample. commodities. Sampling and testing is determined by a series of vertical product-specific standards comprised of GOST and na- In general, the European Union framework for the con- tional standards of member states. Since the Customs trol of microbiological and chemical hazards in food is Union does not have a full-fledged risk-based system, it more risk-based. The differences listed above should does not have all-union risk-based sampling plans nor make a potential food exporter ready for extensive test- does it have detailed harmonized methods for sampling. ing for microbiological and chemical safety criteria when Official laboratories in general operate within national the products are intended for the market of the Customs ISO 17025 accreditation system but in many cases are Union. The positive side to this is that the testing will be not accredited internationally. limited only to those microorganisms specified in the applicable technical regulations or relevant standards. As the European Union’s food control system is based Those who present their product to the European Union on a risk-based approach, laboratories, sampling and market should be ready for testing as well, which will, testing play a far greater role in the overall program. The most likely, be limited to a smaller number of microor- European Union has a much greater degree of specificity ganisms and substances, but in most cases will be done in roles and responsibilities for laboratories and uses ISO according to statistically more stringent rules. 17025 as the core of the accreditation system for food laboratories creating a transparent framework based on Because of the nature of some hazards, in particular, international standards for accreditation. Further, labora- pharmacologically active substances and plant protec- tories are expected to provide additional support to the tion products, and the fact that they are deliberately community in terms of their role in food safety. They used, it is important to know the requirements of the are expected to support the inspection agencies, pro- target market before the production of food begins, as vide support in times of disease outbreak, develop new the level of their residues is a direct consequence of the standards and train laboratory personnel in developing conditions of use. In some cases, producers will have markets as a way to help ensure the safety of the food to revise production strategies and refuse from using stuffs imported from abroad. some substances (for example, certain feed additives or pesticides). In the case of sampling the European Union is highly specific. The European Union clearly defines sampling In the either case, it is important to understand the dif- plans, techniques, tools, labeling, and transportation in ferences in the approaches between the two systems, the regulations. The regulations describe how sampling know how to read the regulations correctly and how is conducted for different types of targets and food ma- to interpret them, and refer to specific criteria in each trixes. The regulations describe considerations dealing particular case. with transportation and sample integrity, traceability, and sampling precautions. The European Regulations take With respect to laboratories, sampling and testing into consideration that sampling and testing will change (analysis) there are significant difference between the over time based on new technologies, information and Customs Union and the European Union approach- risks and have a process to amend and adapt existing es. Fundamentally this is due to the differences in ap- regulations to ensure they are kept relevant and cur- proaches to ensuring food safety. The Customs Union rent with the risks. The European Union has a keen un- approach of control of food safety based on conformity derstanding that in order to compare results across the Comparative Analysis of Certain Requirements of Food Legislation in the European Union 106 and the Customs Union of Russia, Belarus, and Kazakhstan 27 member states it is necessary that they have com- that provide the specificity needed to reproduce the re- mon definitions and a clear understanding of what is sults. These can easily become the basis from which a intended and meant by key terms related to sampling country can rapidly develop appropriate sample proto- and have projects specifically to ensure that harmoniza- cols for a range of products. tion occurs. In the area of testing the European Union policy of al- For governments wishing to harmonize their laws and lowing countries to use specific methods as long as they regulations to both Unions the stark differences in ap- conform to a set of criteria allows for the flexibility that a proach make this fundamentally impractical if not im- country needs in order to provide the appropriate tests possible. The approaches dictate the functions and to ensure food safety. It is not always necessary to have therefore as they are so different it would be impossible the latest expensive and difficult-to-operate equipment to harmonize to both. With regards to laboratories, sam- (e.g., PCR83) when a simple plate test is just as accept- pling and testing the European Union provides possible able and at a significantly lower cost. The flexibility the examples of how government may want to approach European Union has within its legal framework allows these three areas. for this. Laboratory accreditation to ISO 17,025 by a body that is For business operators and exporters the difference be- internationally recognized to grant ISO 17011 accredita- tween the European Union and the Customs Union ap- tions would help ensure that the results from said labo- proaches to food safety criteria will require that they be ratories would be internationally accepted, and provide knowledgeable in the requirements of whichever market the support required to ensure the safety of the food they choose to export into. In addition, business opera- products domestically and internationally. tors and exporters will need to ensure that to whichever Union they export to if they have samples tested prior Further, the approach the European Union has estab- to shipment they must ensure that the samples have lished in allowing their member states to recognize lab- been taken in the appropriate manner consistent with oratories in other member states as part of their control the respective requirements. They will also need to en- program allows countries to save significant financial re- sure that the tests that are performed meet the specific sources in that it reduces the burden of having a broad testing requirements of the market they are exporting range of underutilized and expensive laboratory capac- to, and that the laboratory that conducts the testing ity within their countries as they can leverage the capac- has the systems and processes in place to ensure the ity in another country. quality of the results; moreover, in case of export to the Customs Union, only authorized laboratories located in In the area of sampling and sampling protocols the the Customs Union can be used. European Union has a well-established set of procedures 83 Polymerase chain reaction (PCR) is a molecular biology technique used to amplify a single copy or a few copies of a piece of DNA across several orders of magnitude. Laboratory Control and Food Safety Criteria in the European Union and the Customs Union 107 In partnership with: